RecallHawk
Class II Recall

Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d.

MEDLINE INDUSTRIES, LP - Northfield

Summary

The FDA issued a Class II for Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS by MEDLINE INDUSTRIES, LP - Northfield. Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging..

Details

Source

Device Recall

External ID

Z-1092-2023

Action Date

2023-02-15

Status

Ongoing

Category

device

Product Description

Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-SECTION m. C-SECTION CDS n. C-SECTION PACK-LF o. C-SECTION PACK-LF p. C-SECTION PACK-LF q. C-SECTION PACK-LF r. C-BIRTH PACK-LF s. C SECTION PACK-LF t. C-SECTION PACK-LF u. C SECTION PACK-LF v. C-SECTION PACK-LF w. C SECTION PACK-LF x. C-SECTION PACK-LF y. C-SECTION PACK z. C-SECTION PACK-LF aa. C-SECTION PACK-LF bb. C-SECTION PACK-LF cc. C-SECTION PACK-LF dd. C-BIRTH SETUP PACK-LF ee. C-SECTION PACK-LF ff. C-SECTION PACK-LF gg. C-SECTION PACK-LF hh. C SECTION PACK-LF ii. C-SECTION PACK-LF jj. C-SECTION TRAY kk. C-SECTION PACK ll. C-SECTION PACK-LF mm. C-SECTION PACK nn. C-SECTION PACK oo. C-SECTION pp. C-SECTION PACK qq. SVMMC C-SECTION PACK rr. C-SECTION PACK-LF ss. C-SECTION SETUP PACK tt. C-SECTION PACK uu. C-SECTION PACK vv. C-SECTION PACK *STANDARD* ww. C-SECTION PACK xx. C-SECTION PACK yy. C-SECTION PACK zz. C-SECTION 83305, MERCY REG aaa. CUH C-SECTION PACK-LF bbb. C-SECTION PACK-LF ccc. C-SECTION PACK ddd. C-SECTION PACK eee. C-SECTION PACK fff. C-SECTION PK ggg. C-SECTION hhh. C-SECTION PACK iii. ST JO WEST C-SECTION BASIN-LF jjj. C SECTION PACK kkk. C-SECTION PACK lll. C SECTION PACK mmm. C SECTION DELIVERY nnn. C-SECTION PACK ooo. C-SECTION PACK ppp. C SECTION qqq. WR C SECTION PACK-LF rrr. C-SECTION PACK sss. PK, L&D-C SECTION ttt. C-SECTION PACK HIGHLAND-LF uuu. C- SECTION vvv. C SECTION PACK-LF www. C-SECTION PACK xxx. C-SECTION PACK yyy. C SECTION PACK zzz. PK, L&D-C SECTION aaaa. C SECTION PACK bbbb. C SECTION PACK cccc. C-SECTION PACK dddd. SECTION PACK (CSSJE)642-LF eeee. C-SECTION PACK ffff. C-SECTION PACK-RFD gggg. C-SECTION DELIVERY PACK-LF hhhh. C-SECTION PACK iiii. C SECTION PACK jjjj. C-SECTION PACK kkkk. C SECTION llll. C SECTION PLUS PACK mmmm. C SECTION PACK-6220 nnnn. C-SECTION PACK oooo. C-SECTION PACK pppp. C-SECTION PACK - WCH qqqq. C SECTION WITH BASIN PACK rrrr. PHP C-SECTION PACK-LF ssss. C-SECTION KIT tttt. C SECTION PACK uuuu. C-SECTION vvvv. C-SECTION I PACK-LF wwww. C-SECTION PACK 2 xxxx. C-SECTION PACK-LF yyyy. C-SECTION PACK zzzz. C-SECTION PACK aaaaa. C SECTION PACK bbbbb. C-SECTION PACK ccccc. C SECTION ddddd. C SECTION PACK-LF eeeee. C SECTION PACK-LF fffff. BSMI CSECTION BIRTHING PACK ggggg. C-SECTION PACK hhhhh. C SECTION PACK-LF iiiii. C-SECTION PACK jjjjj. C SECTION PACK kkkkk. C SECTION lllll. PK, L&D-C SECTION mmmmm. C-SECTION PACK nnnnn. C SECTION ooooo. C-SECTION PACK ppppp. C-SECTION SMMC qqqqq. C SECTION PACK rrrrr. C SECTION PACK sssss. C-SECTION PACK ttttt. C SECTION #2 SHARED uuuuu. C SECTION #3 SHARED vvvvv. C SECTION wwwww. C-SECTION PACK xxxxx. CESAREAN BIRTH PACK yyyyy. C SECTION PACK-LF zzzzz. C-SECTION PACK aaaaaa. C-SECTION PACK-LF bbbbbb. C SECTION PACK cccccc. C-SECTION PACK dddddd. C-SECTION eeeeee. C-SECTION ffffff. C SECTION gggggg. C-SECTION hhhhhh. C SECTION iiiiii. C-SECTION jjjjjj. C-SECTION kkkkkk. PROHEALTH C-SECTION llllll. C SECTION mmmmmm. C SECTION nnnnnn. C-SECTION oooooo. C-SECTION pppppp. C-SECTION PACK qqqqqq. C SECTION rrrrrr. C SECTION ssssss. C-SECTION tttttt. C SECTION uuuuuu. C-SECTION - SMH vvvvvv. C-SECTION MRMC wwwwww. SCHED C SECTION xxxxxx. C-SECTION yyyyyy. C-SECTION -LF zzzzzz. ADVENTIST C-SECTION PACK aaaaaaa. C-SECTION PK-LF bbbbbbb. C-SECTION PROCEDURE ccccccc. C-SECTION II-LF ddddddd. C-SECTION I-LF eeeeeee. C-SECTION PACK fffffff. C-BIRTH PACK-LF ggggggg. C-SECTION PACK hhhhhhh. THEDACARE C-SECTION iiiiiii. C-SECTION BASIN PACK jjjjjjj. C-SECTION PACK kkkkkkk. C-SECTION PACK-LF lllllll. PPH C-SECTION PACK-LF mmmmmmm. C SECTION PACK-LF nnnnnnn. C-SECTION PACK ooooooo. C-SECTION PACK-LF

Lot/Code Info: a. C-SECTION OR 30 CDS, Item Number: CDS820075W, Case UDI/GTIN: 40195327209798, Unit UDI/GTIN: 10195327209797, Lot Number: 22JBX603,22JBX483; b. C-SECTION CDS, Item Number: CDS830218J, Case UDI/GTIN: 40888277530172, Unit UDI/GTIN: 10888277530171, Lot Number: 22JBV584; c. C-SECTION CDS, Item Number: CDS980747J, Case UDI/GTIN: 40193489923613, Unit UDI/GTIN: 10193489923612, Lot Number: 22JBO006; d. C-SECTION CDS, Item Number: CDS981430C, Case UDI/GTIN: 40193489260879, Unit UDI/GTIN: 10193489260878, Lot Number: 22JMG179; e. MAJOR ORTHO CDS-LF, Item Number: CDS982233G, Case UDI/GTIN: 40193489986212, Unit UDI/GTIN: 10193489986211, Lot Number: 22JMG573; f. C-SECTION CDS, Item Number: CDS982367I, Case UDI/GTIN: 40193489312349, Unit UDI/GTIN: 10193489312348, Lot Number: 22KBE753,22KBC690; g. C-SECTION CDS, Item Number: CDS983117G, Case UDI/GTIN: 40195327192113, Unit UDI/GTIN: 10195327192112, Lot Number: 22IBR943; h. C-SECTION PROCEDURE, Item Number: CDS983450L, Case UDI/GTIN: 40193489372336, Unit UDI/GTIN: 10193489372335, Lot Number: 22KBE444,22IBD865,22IBE112; i. C-SECTION CDS-LF, Item Number: CDS983869I, Case UDI/GTIN: 40888277752734, Unit UDI/GTIN: 10888277752733, Lot Number: 22JDB259; j. C-SECTION CDS, Item Number: CDS983917M, Case UDI/GTIN: 40193489402712, Unit UDI/GTIN: 10193489402711, Lot Number: 22JBO248; k. C-SECTION CDS, Item Number: CDS984354C, Case UDI/GTIN: 40193489738187, Unit UDI/GTIN: 10193489738186, Lot Number: 22JBC335; l. C-SECTION, Item Number: CDS984902K, Case UDI/GTIN: 40195327156924, Unit UDI/GTIN: 10195327156923, Lot Number: 22IBQ711,22IBL648; m. C-SECTION CDS, Item Number: CDS985206B, Case UDI/GTIN: 40889942942078, Unit UDI/GTIN: 10889942942077, Lot Number: 22JBL398; n. C-SECTION PACK-LF, Item Number: DYNJ0173422AF, Case UDI/GTIN: 40195327097579, Unit UDI/GTIN: 10195327097578, Lot Number: 22JMA807; o. C-SECTION PACK-LF, Item Number: DYNJ0188507C, Case UDI/GTIN: 40889942053491, Unit UDI/GTIN: 10889942053490, Lot Number: 22JBY657,22IBI286; p. C-SECTION PACK-LF, Item Number: DYNJ0200274P, Case UDI/GTIN: 40889942054115, Unit UDI/GTIN: 10889942054114, Lot Number: 22IMG322; q. C-SECTION PACK-LF, Item Number: DYNJ0365888N, Case UDI/GTIN: 40195327045273, Unit UDI/GTIN: 10195327045272, Lot Number: 22IMF444,22HMF014; r. C-BIRTH PACK-LF, Item Number: DYNJ0366291M, Case UDI/GTIN: 40889942059615, Unit UDI/GTIN: 10889942059614, Lot Number: 22IME718; s. C SECTION PACK-LF, Item Number: DYNJ0367189M, Case UDI/GTIN: 40193489788298, Unit UDI/GTIN: 10193489788297, Lot Number: 22IMG638,22HMC273; t. C-SECTION PACK-LF, Item Number: DYNJ0367679W, Case UDI/GTIN: 40193489617369, Unit UDI/GTIN: 10193489617368, Lot Number: 22JMI197,22IMD016; u. C SECTION PACK-LF, Item Number: DYNJ0376534Q, Case UDI/GTIN: 40195327237173, Unit UDI/GTIN: 10195327237172, Lot Number: 22IBE468; v. C-SECTION PACK-LF, Item Number: DYNJ0382235G, Case UDI/GTIN: 40889942435020, Unit UDI/GTIN: 10889942435029, Lot Number: 22IBC549,22IBC247,22HBG107; w. C SECTION PACK-LF, Item Number: DYNJ0397841N, Case UDI/GTIN: 40193489824064, Unit UDI/GTIN: 10193489824063, Lot Number: 22IBL780; x. C-SECTION PACK-LF, Item Number: DYNJ04609I, Case UDI/GTIN: 40193489552707, Unit UDI/GTIN: 10193489552706, Lot Number: 22IMA202; y. C-SECTION PACK, Item Number: DYNJ04620S, Case UDI/GTIN: 40195327135851, Unit UDI/GTIN: 10195327135850, Lot Number: 22IMB266; z. C-SECTION PACK-LF, Item Number: DYNJ04724Q, Case UDI/GTIN: 40193489554015, Unit UDI/GTIN: 10193489554014, Lot Number: 22IMF982; aa. C-SECTION PACK-LF, Item Number: DYNJ0508830M, Case UDI/GTIN: 40193489579247, Unit UDI/GTIN: 10193489579246, Lot Number: 22IMD130; bb. C-SECTION PACK-LF, Item Number: DYNJ0551773O, Case UDI/GTIN: 40193489268622, Unit UDI/GTIN: 10193489268621, Lot Number: 22JBS505; cc. C-SECTION PACK-LF, Item Number: DYNJ06584K, Case UDI/GTIN: 40193489420525, Unit UDI/GTIN: 10193489420524, Lot Number: 22JBY658,22IBU471,22HBL261; dd. C-BIRTH SETUP PACK-LF, Item Number: DYNJ0781722T, Case UDI/GTIN: 40193489226356, Unit UDI/GTIN: 10193489226355, Lot Number: 22JMG062; ee. C-SECTION PACK-LF, Item Number: DYNJ07836Q, Case UDI/GTIN: 40195327209552, Unit UDI/GTIN: 10195327209551, Lot Number: 22IBO410; ff. C-SECTION PACK-LF, Item Number: DYNJ0842739K, Case UDI/GTIN: 40193489359634, Unit UDI/GTIN: 10193489359633, Lot Number: 22JDB302; gg. C-SECTION PACK-LF, Item Number: DYNJ0843654G, Case UDI/GTIN: 40889942402855, Unit UDI/GTIN: 10889942402854, Lot Number: 22IDB683,22IDA305; hh. C SECTION PACK-LF, Item Number: DYNJ0923021, Case UDI/GTIN: 40889942099642, Unit UDI/GTIN: 10889942099641, Lot Number: 22JMH549,22IMF460; ii. C-SECTION PACK-LF, Item Number: DYNJ15232M, Case UDI/GTIN: 40195327231744, Unit UDI/GTIN: 10195327231743, Lot Number: 22IMH405; jj. C-SECTION TRAY, Item Number: DYNJ15494G, Case UDI/GTIN: 40193489961196, Unit UDI/GTIN: 10193489961195, Lot Number: 22IBI076; kk. C-SECTION PACK, Item Number: DYNJ15726I, Case UDI/GTIN: 40193489832403, Unit UDI/GTIN: 10193489832402, Lot Number: 22JBU168; ll. C-SECTION PACK-LF, Item Number: DYNJ16672I, Case UDI/GTIN: 40193489990752, Unit UDI/GTIN: 10193489990751, Lot Number: 22JBK965,22IBL997,22HBU474,22HBV462; mm. C-SECTION PACK, Item Number: DYNJ19958P, Case UDI/GTIN: 40193489867733, Unit UDI/GTIN: 10193489867732, Lot Number: 22JMI344,22IMG005,22HME230; nn. C-SECTION PACK, Item Number: DYNJ20135M, Case UDI/GTIN: 40193489905534, Unit UDI/GTIN: 10193489905533, Lot Number: 22JBS400; oo. C-SECTION, Item Number: DYNJ22368I, Case UDI/GTIN: 40193489780513, Unit UDI/GTIN: 10193489780512, Lot Number: 22IBN332; pp. C-SECTION PACK, Item Number: DYNJ24120C, Case UDI/GTIN: 40884389396507, Unit UDI/GTIN: 10884389396506, Lot Number: 22IBF425; qq. SVMMC C-SECTION PACK, Item Number: DYNJ24632K, Case UDI/GTIN: 40195327058624, Unit UDI/GTIN: 10195327058623, Lot Number: 22JLB138,22ILA591; rr. C-SECTION PACK-LF, Item Number: DYNJ26665J, Case UDI/GTIN: 40889942112136, Unit UDI/GTIN: 10889942112135, Lot Number: 22JBW002; ss. C-SECTION SETUP PACK, Item Number: DYNJ27751F, Case UDI/GTIN: 40195327228706, Unit UDI/GTIN: 10195327228705, Lot Number: 22JDA003,22HDC395,22HDA918; tt. C-SECTION PACK, Item Number: DYNJ29034F, Case UDI/GTIN: 40193489461146, Unit UDI/GTIN: 10193489461145, Lot Number: 22IME948; uu. C-SECTION PACK, Item Number: DYNJ30483F, Case UDI/GTIN: 40193489912419, Unit UDI/GTIN: 10193489912418, Lot Number: 22JMB299,22HMB825; vv. C-SECTION PACK *STANDARD*, Item Number: DYNJ30609G, Case UDI/GTIN: 40193489301541, Unit UDI/GTIN: 10193489301540, Lot Number: 22IMG006; ww. C-SECTION PACK, Item Number: DYNJ30610D, Case UDI/GTIN: 40889942491972, Unit UDI/GTIN: 10889942491971, Lot Number: 22HDC051; xx. C-SECTION PACK, Item Number: DYNJ31011D, Case UDI/GTIN: 40889942383413, Unit UDI/GTIN: 10889942383412, Lot Number: 22JBR171; yy. C-SECTION PACK, Item Number: DYNJ32011G, Case UDI/GTIN: 40195327067046, Unit UDI/GTIN: 10195327067045, Lot Number: 22JMH079; zz. C-SECTION 83305, MERCY REG, Item Number: DYNJ32059F, Case UDI/GTIN: 40193489822497, Unit UDI/GTIN: 10193489822496, Lot Number: 22IBV950; aaa. CUH C-SECTION PACK-LF, Item Number: DYNJ32253G, Case UDI/GTIN: 40195327066537, Unit UDI/GTIN: 10195327066536, Lot Number: 22IBJ049; bbb. C-SECTION PACK-LF, Item Number: DYNJ33059B, Case UDI/GTIN: 40193489950947, Unit UDI/GTIN: 10193489950946, Lot Number: 22JBO407,22IBG828,22HBR300; ccc. C-SECTION PACK, Item Number: DYNJ33188B, Case UDI/GTIN: 40888277746283, Unit UDI/GTIN: 10888277746282, Lot Number: 22JMH212,22IMI213; ddd. C-SECTION PACK, Item Number: DYNJ33550B, Case UDI/GTIN: 40889942435686, Unit UDI/GTIN: 10889942435685, Lot Number: 22JMF403; eee. C-SECTION PACK, Item Number: DYNJ33799C, Case UDI/GTIN: 40889942447153, Unit UDI/GTIN: 10889942447152, Lot Number: 22JBI238,22HBG189; fff. C-SECTION PK, Item Number: DYNJ34266B, Case UDI/GTIN: 40888277246516, Unit UDI/GTIN: 10888277246515, Lot Number: 22IBK679; ggg. C-SECTION, Item Number: DYNJ34431G, Case UDI/GTIN: 40193489834957, Unit UDI/GTIN: 10193489834956, Lot Number: 22JBN841; hhh. C-SECTION PACK, Item Number: DYNJ36310K, Case UDI/GTIN: 40193489443456, Unit UDI/GTIN: 10193489443455, Lot Number: 22JMG326; iii. ST JO WEST C-SECTION BASIN-LF, Item Number: DYNJ37027A, Case UDI/GTIN: 40889942418320, Unit UDI/GTIN: 10889942418329, Lot Number: 22JBR330,22HBT598; jjj. C SECTION PACK, Item Number: DYNJ37622C, Case UDI/GTIN: 40884389864235, Unit UDI/GTIN: 10884389864234, Lot Number: 22IBT225; kkk. C-SECTION PACK, Item Number: DYNJ38350J, Case UDI/GTIN: 40195327129959, Unit UDI/GTIN: 10195327129958, Lot Number: 22JMC173,22IME739,22HMD564; lll. C SECTION PACK, Item Number: DYNJ38440C, Case UDI/GTIN: 40195327061792, Unit UDI/GTIN: 10195327061791, Lot Number: 22JMC367,22IMF067; mmm. C SECTION DELIVERY, Item Number: DYNJ39375F, Case UDI/GTIN: 40193489418980, Unit UDI/GTIN: 10193489418989, Lot Number: 22IBG340; nnn. C-SECTION PACK, Item Number: DYNJ40458B, Case UDI/GTIN: 40889942109334, Unit UDI/GTIN: 10889942109333, Lot Number: 22IBS430,22HBH047; ooo. C-SECTION PACK, Item Number: DYNJ40503B, Case UDI/GTIN: 40193489614931, Unit UDI/GTIN: 10193489614930, Lot Number: 22IDB276; ppp. C SECTION, Item Number: DYNJ41268B, Case UDI/GTIN: 40193489487627, Unit UDI/GTIN: 10193489487626, Lot Number: 22IMF995,22IMF998; qqq. WR C SECTION PACK-LF, Item Number: DYNJ41570K, Case UDI/GTIN: 40195327089772, Unit UDI/GTIN: 10195327089771, Lot Number: 22IMF970,22IMG359; rrr. C-SECTION PACK, Item Number: DYNJ42226D, Case UDI/GTIN: 40195327017935, Unit UDI/GTIN: 10195327017934, Lot Number: 22IMG051,22IMG068; sss. PK, L&D-C SECTION, Item Number: DYNJ42476I, Case UDI/GTIN: 40193489266017, Unit UDI/GTIN: 10193489266016, Lot Number: 22JBU242; ttt. C-SECTION PACK HIGHLAND-LF, Item Number: DYNJ42634B, Case UDI/GTIN: 40888277582805, Unit UDI/GTIN: 10888277582804, Lot Number: 22IBD370; uuu. C- SECTION, Item Number: DYNJ42651, Case UDI/GTIN: 40888277003584, Unit UDI/GTIN: 10888277003583, Lot Number: 22IME346,22IME347,22HMC131; vvv. C SECTION PACK-LF, Item Number: DYNJ42850A, Case UDI/GTIN: 40193489880909, Unit UDI/GTIN: 10193489880908, Lot Number: 22JBN852; www. C-SECTION PACK, Item Number: DYNJ42946A, Case UDI/GTIN: 40195327196838, Unit UDI/GTIN: 10195327196837, Lot Number: 22IBV689,22HBH787; xxx. C-SECTION PACK, Item Number: DYNJ43284D, Case UDI/GTIN: 40888277984128, Unit UDI/GTIN: 10888277984127, Lot Number: 22IMG361; yyy. C SECTION PACK, Item Number: DYNJ43732F, Case UDI/GTIN: 40193489549370, Unit UDI/GTIN: 10193489549379, Lot Number: 22IBI952; zzz. PK, L&D-C SECTION, Item Number: DYNJ43746C, Case UDI/GTIN: 40193489310635, Unit UDI/GTIN: 10193489310634, Lot Number: 22JBO122; aaaa. C SECTION PACK, Item Number: DYNJ43810A, Case UDI/GTIN: 40193489298056, Unit UDI/GTIN: 10193489298055, Lot Number: 22IBK239; bbbb. C SECTION PACK, Item Number: DYNJ46508F, Case UDI/GTIN: 40195327111787, Unit UDI/GTIN: 10195327111786, Lot Number: 22JME929; cccc. C-SECTION PACK, Item Number: DYNJ47220C, Case UDI/GTIN: 40889942131359, Unit UDI/GTIN: 10889942131358, Lot Number: 22JMD043; dddd. SECTION PACK (CSSJE)642-LF, Item Number: DYNJ47485C, Case UDI/GTIN: 40193489586597, Unit UDI/GTIN: 10193489586596, Lot Number: 22IMI230; eeee. C-SECTION PACK, Item Number: DYNJ47606B, Case UDI/GTIN: 40193489730693, Unit UDI/GTIN: 10193489730692, Lot Number: 22IBV197; ffff. C-SECTION PACK-RFD, Item Number: DYNJ47761K, Case UDI/GTIN: 40193489896986, Unit UDI/GTIN: 10193489896985, Lot Number: 22IME390; gggg. C-SECTION DELIVERY PACK-LF, Item Number: DYNJ47808F, Case UDI/GTIN: 40195327232604, Unit UDI/GTIN: 10195327232603, Lot Number: 22IMB729; hhhh. C-SECTION PACK, Item Number: DYNJ48272, Case UDI/GTIN: 40888277575371, Unit UDI/GTIN: 10888277575370, Lot Number: 22IBO504,22HMD672; iiii. C SECTION PACK, Item Number: DYNJ48483D, Case UDI/GTIN: 40195327030811, Unit UDI/GTIN: 10195327030810, Lot Number: 22JMI251; jjjj. C-SECTION PACK, Item Number: DYNJ48746A, Case UDI/GTIN: 40889942385691, Unit UDI/GTIN: 10889942385690, Lot Number: 22JMA582; kkkk. C SECTION, Item Number: DYNJ49172G, Case UDI/GTIN: 40193489308243, Unit UDI/GTIN: 10193489308242, Lot Number: 22IMC797,22HME909; llll. C SECTION PLUS PACK, Item Number: DYNJ49370D, Case UDI/GTIN: 40193489213318, Unit UDI/GTIN: 10193489213317, Lot Number: 22JBO103,22HBR997,22HBG119; mmmm. C SECTION PACK-6220, Item Number: DYNJ49519A, Case UDI/GTIN: 40889942024835, Unit UDI/GTIN: 10889942024834, Lot Number: 22IBN420; nnnn. C-SECTION PACK, Item Number: DYNJ49668A, Case UDI/GTIN: 40889942390176, Unit UDI/GTIN: 10889942390175, Lot Number: 22JBS277,22IBR285; oooo. C-SECTION PACK, Item Number: DYNJ49771, Case UDI/GTIN: 40888277881144, Unit UDI/GTIN: 10888277881143, Lot Number: 22IBQ282; pppp. C-SECTION PACK - WCH, Item Number: DYNJ49829F, Case UDI/GTIN: 40193489631570, Unit UDI/GTIN: 10193489631579, Lot Number: 22JBX669; qqqq. C SECTION WITH BASIN PACK, Item Number: DYNJ51378G, Case UDI/GTIN: 40193489996389, Unit UDI/GTIN: 10193489996388, Lot Number: 22IBN196; rrrr. PHP C-SECTION PACK-LF, Item Number: DYNJ51603D, Case UDI/GTIN: 40195327167050, Unit UDI/GTIN: 10195327167059, Lot Number: 22JMG359,22IMA243; ssss. C-SECTION KIT, Item Number: DYNJ51655C, Case UDI/GTIN: 40195327187850, Unit UDI/GTIN: 10195327187859, Lot Number: 22IME130; tttt. C SECTION PACK, Item Number: DYNJ51872D, Case UDI/GTIN: 40195327043439, Unit UDI/GTIN: 10195327043438, Lot Number: 22JBI664; uuuu. C-SECTION, Item Number: DYNJ51997, Case UDI/GTIN: 40889942233107, Unit UDI/GTIN: 10889942233106, Lot Number: 22JBP756,22IBR427; vvvv. C-SECTION I PACK-LF, Item Number: DYNJ52040F, Case UDI/GTIN: 40195327096145, Unit UDI/GTIN: 10195327096144, Lot Number: 22JBO202,22JBN048,22HBG758; wwww. C-SECTION PACK 2, Item Number: DYNJ52168A, Case UDI/GTIN: 40193489539739, Unit UDI/GTIN: 10193489539738, Lot Number: 22JBD226,22IBP554,22IBM605; xxxx. C-SECTION PACK-LF, Item Number: DYNJ52908A, Case UDI/GTIN: 40889942851981, Unit UDI/GTIN: 10889942851980, Lot Number: 22IMC339,22HMC091; yyyy. C-SECTION PACK, Item Number: DYNJ52931D, Case UDI/GTIN: 40195327200221, Unit UDI/GTIN: 10195327200220, Lot Number: 22IBR773; zzzz. C-SECTION PACK, Item Number: DYNJ53386C, Case UDI/GTIN: 40195327169696, Unit UDI/GTIN: 10195327169695, Lot Number: 22JMF746; aaaaa. C SECTION PACK, Item Number: DYNJ53399I, Case UDI/GTIN: 40193489968478, Unit UDI/GTIN: 10193489968477, Lot Number: 22JMF705; bbbbb. C-SECTION PACK, Item Number: DYNJ53598F, Case UDI/GTIN: 40195327055821, Unit UDI/GTIN: 10195327055820, Lot Number: 22IMB353,22IMB057; ccccc. C SECTION, Item Number: DYNJ53654F, Case UDI/GTIN: 40193489454674, Unit UDI/GTIN: 10193489454673, Lot Number: 22IBI089; ddddd. C SECTION PACK-LF, Item Number: DYNJ54186A, Case UDI/GTIN: 40195327062607, Unit UDI/GTIN: 10195327062606, Lot Number: 22JMF820; eeeee. C SECTION PACK-LF, Item Number: DYNJ54374J, Case UDI/GTIN: 40193489404075, Unit UDI/GTIN: 10193489404074, Lot Number: 22IBM226; fffff. BSMI CSECTION BIRTHING PACK, Item Number: DYNJ54946G, Case UDI/GTIN: 40195327135455, Unit UDI/GTIN: 10195327135454, Lot Number: 22IBJ472,22HBA609; ggggg. C-SECTION PACK, Item Number: DYNJ55336A, Case UDI/GTIN: 40889942781097, Unit UDI/GTIN: 10889942781096, Lot Number: 22KBB430; hhhhh. C SECTION PACK-LF, Item Number: DYNJ55466C, Case UDI/GTIN: 40193489408158, Unit UDI/GTIN: 10193489408157, Lot Number: 22IBN820,22HBW539; iiiii. C-SECTION PACK, Item Number: DYNJ55719, Case UDI/GTIN: 40889942574590, Unit UDI/GTIN: 10889942574599, Lot Number: 22IBR318; jjjjj. C SECTION PACK, Item Number: DYNJ57193A, Case UDI/GTIN: 40193489647656, Unit UDI/GTIN: 10193489647655, Lot Number: 22IBF463; kkkkk. C SECTION, Item Number: DYNJ57622, Case UDI/GTIN: 40889942757245, Unit UDI/GTIN: 10889942757244, Lot Number: 22IBF901; lllll. PK, L&D-C SECTION, Item Number: DYNJ58239B, Case UDI/GTIN: 40195327248766, Unit UDI/GTIN: 10195327248765, Lot Number: 22IMH256,22IMH497; mmmmm. C-SECTION PACK, Item Number: DYNJ58493A, Case UDI/GTIN: 40193489517423, Unit UDI/GTIN: 10193489517422, Lot Number: 22JBU325; nnnnn. C SECTION, Item Number: DYNJ58551, Case UDI/GTIN: 40889942870982, Unit UDI/GTIN: 10889942870981, Lot Number: 22JBO158; ooooo. C-SECTION PACK, Item Number: DYNJ59414A, Case UDI/GTIN: 40195327066452, Unit UDI/GTIN: 10195327066451, Lot Number: 22JMF097; ppppp. C-SECTION SMMC, Item Number: DYNJ59457A, Case UDI/GTIN: 40195327243266, Unit UDI/GTIN: 10195327243265, Lot Number: 22JMD987; qqqqq. C SECTION PACK, Item Number: DYNJ61573, Case UDI/GTIN: 40193489601078, Unit UDI/GTIN: 10193489601077, Lot Number: 22JMA868,22IMF177; rrrrr. C SECTION PACK, Item Number: DYNJ64493A, Case UDI/GTIN: 40193489323260, Unit UDI/GTIN: 10193489323269, Lot Number: 22IBI098; sssss. C-SECTION PACK, Item Number: DYNJ64678A, Case UDI/GTIN: 40195327225996, Unit UDI/GTIN: 10195327225995, Lot Number: 22JDB087; ttttt. C SECTION #2 SHARED, Item Number: DYNJ64773C, Case UDI/GTIN: 40195327221066, Unit UDI/GTIN: 10195327221065, Lot Number: 22IDA431; uuuuu. C SECTION #3 SHARED, Item Number: DYNJ64774D, Case UDI/GTIN: 40195327233885, Unit UDI/GTIN: 10195327233884, Lot Number: 22IDC063,22IDA788; vvvvv. C SECTION, Item Number: DYNJ65646B, Case UDI/GTIN: 40195327146789, Unit UDI/GTIN: 10195327146788, Lot Number: 22IBF374; wwwww. C-SECTION PACK, Item Number: DYNJ65961B, Case UDI/GTIN: 40193489984300, Unit UDI/GTIN: 10193489984309, Lot Number: 22IME243; xxxxx. CESAREAN BIRTH PACK, Item Number: DYNJ67620, Case UDI/GTIN: 40193489418164, Unit UDI/GTIN: 10193489418163, Lot Number: 22JBX125,22HBR751,22HBS988; yyyyy. C SECTION PACK-LF, Item Number: DYNJ67957, Case UDI/GTIN: 40193489458979, Unit UDI/GTIN: 10193489458978, Lot Number: 22JMH427,22JMD099,22IMH525; zzzzz. C-SECTION PACK, Item Number: DYNJ68954, Case UDI/GTIN: 40193489863469, Unit UDI/GTIN: 10193489863468, Lot Number: 22JMF850; aaaaaa. C-SECTION PACK-LF, Item Number: DYNJ69445, Case UDI/GTIN: 40193489942515, Unit UDI/GTIN: 10193489942514, Lot Number: 22JBR185,22IBG076; bbbbbb. C SECTION PACK, Item Number: DYNJ82554, Case UDI/GTIN: 40195327198245, Unit UDI/GTIN: 10195327198244, Lot Number: 22JBQ815; cccccc. C-SECTION PACK, Item Number: DYNJ83021, Case UDI/GTIN: 40195327228911, Unit UDI/GTIN: 10195327228910, Lot Number: 22JBN586; dddddd. C-SECTION, Item Number: DYNJ900260A, Case UDI/GTIN: 40195327178537, Unit UDI/GTIN: 10195327178536, Lot Number: 22IBQ946; eeeeee. C-SECTION, Item Number: DYNJ900266C, Case UDI/GTIN: 40193489278430, Unit UDI/GTIN: 10193489278439, Lot Number: 22IBS357; ffffff. C SECTION, Item Number: DYNJ900794, Case UDI/GTIN: 40888277906601, Unit UDI/GTIN: 10888277906600, Lot Number: 22KBF556,22JBM372,22IBI225; gggggg. C-SECTION, Item Number: DYNJ902761D, Case UDI/GTIN: 40193489891059, Unit UDI/GTIN: 10193489891058, Lot Number: 22JMG886,22JMD346; hhhhhh. C SECTION, Item Number: DYNJ903771B, Case UDI/GTIN: 40193489935968, Unit UDI/GTIN: 10193489935967, Lot Number: 22JBN602,22JBN603,22HBX117; iiiiii. C-SECTION, Item Number: DYNJ904357D, Case UDI/GTIN: 40195327223091, Unit UDI/GTIN: 10195327223090, Lot Number: 22JBE816,22IBR279; jjjjjj. C-SECTION, Item Number: DYNJ904612F, Case UDI/GTIN: 40193489844048, Unit UDI/GTIN: 10193489844047, Lot Number: 22JBA083; kkkkkk. PROHEALTH C-SECTION, Item Number: DYNJ904879D, Case UDI/GTIN: 40193489400107, Unit UDI/GTIN: 10193489400106, Lot Number: 22KBC325; llllll. C SECTION, Item Number: DYNJ905314G, Case UDI/GTIN: 40193489930536, Unit UDI/GTIN: 10193489930535, Lot Number: 22JBR953; mmmmmm. C SECTION, Item Number: DYNJ905776C, Case UDI/GTIN: 40195327179862, Unit UDI/GTIN: 10195327179861, Lot Number: 22KBF490; nnnnnn. C-SECTION, Item Number: DYNJ905792C, Case UDI/GTIN: 40195327108428, Unit UDI/GTIN: 10195327108427, Lot Number: 22IMF389; oooooo. C-SECTION, Item Number: DYNJ906470D, Case UDI/GTIN: 40195327204243, Unit UDI/GTIN: 10195327204242, Lot Number: 22IDC048; pppppp. C-SECTION PACK, Item Number: DYNJ906557A, Case UDI/GTIN: 40193489436373, Unit UDI/GTIN: 10193489436372, Lot Number: 22IBT728; qqqqqq. C SECTION, Item Number: DYNJ906917A, Case UDI/GTIN: 40193489460378, Unit UDI/GTIN: 10193489460377, Lot Number: 22JBJ828; rrrrrr. C SECTION, Item Number: DYNJ907073, Case UDI/GTIN: 40193489337069, Unit UDI/GTIN: 10193489337068, Lot Number: 22IBE728; ssssss. C-SECTION, Item Number: DYNJ907228F, Case UDI/GTIN: 40195327247448, Unit UDI/GTIN: 10195327247447, Lot Number: 22JBC329; tttttt. C SECTION, Item Number: DYNJ907660A, Case UDI/GTIN: 40195327168668, Unit UDI/GTIN: 10195327168667, Lot Number: 22IMG417; uuuuuu. C-SECTION - SMH, Item Number: DYNJ907724A, Case UDI/GTIN: 40193489976381, Unit UDI/GTIN: 10193489976380, Lot Number: 22JBH655,22IBA564; vvvvvv. C-SECTION MRMC, Item Number: DYNJ907745B, Case UDI/GTIN: 40195327195411, Unit UDI/GTIN: 10195327195410, Lot Number: 22KBE700,22IBE731,22HBU387; wwwwww. SCHED C SECTION, Item Number: DYNJ907956, Case UDI/GTIN: 40193489949439, Unit UDI/GTIN: 10193489949438, Lot Number: 22IBQ951; xxxxxx. C-SECTION, Item Number: DYNJ908197, Case UDI/GTIN: 40195327006502, Unit UDI/GTIN: 10195327006501, Lot Number: 22JDB121; yyyyyy. C-SECTION -LF, Item Number: DYNJ9932207R, Case UDI/GTIN: 40193489624152, Unit UDI/GTIN: 10193489624151, Lot Number: 22JMD352; zzzzzz. ADVENTIST C-SECTION PACK, Item Number: DYNJADV101A, Case UDI/GTIN: 40888277576170, Unit UDI/GTIN: 10888277576179, Lot Number: 22IBS980,22HBW715; aaaaaaa. C-SECTION PK-LF, Item Number: DYNJC2363J, Case UDI/GTIN: 40195327131341, Unit UDI/GTIN: 10195327131340, Lot Number: 22HBI849,22HBI850; bbbbbbb. C-SECTION PROCEDURE, Item Number: DYNJQ9038I, Case UDI/GTIN: 40889942629948, Unit UDI/GTIN: 10889942629947, Lot Number: 22HBR429; ccccccc. C-SECTION II-LF, Item Number: DYNJS0612, Case UDI/GTIN: 40080196942504, Unit UDI/GTIN: 10080196942503, Lot Number: 22JBK525,22IBP836,22HBX278,22HBN836,22HBG183,22HBG185; ddddddd. C-SECTION I-LF, Item Number: DYNJS3038, Case UDI/GTIN: 40884389450216, Unit UDI/GTIN: 10884389450215, Lot Number: 22JDA185,22HDC283,22HDB455,22HDA724; eeeeeee. C-SECTION PACK, Item Number: DYNJT0473I, Case UDI/GTIN: 40889942954057, Unit UDI/GTIN: 10889942954056, Lot Number: 22IMH365; fffffff. C-BIRTH PACK-LF, Item Number: DYNJT1915K, Case UDI/GTIN: 40193489899376, Unit UDI/GTIN: 10193489899375, Lot Number: 22IBN792,22IBE982; ggggggg. C-SECTION PACK, Item Number: OBJ602U, Case UDI/GTIN: 40193489964470, Unit UDI/GTIN: 10193489964479, Lot Number: 22JBP919,22IBK343; hhhhhhh. THEDACARE C-SECTION, Item Number: OBP112X, Case UDI/GTIN: 40195327147649, Unit UDI/GTIN: 10195327147648, Lot Number: 22HBB733; iiiiiii. C-SECTION BASIN PACK, Item Number: OBP211C, Case UDI/GTIN: 40884389069746, Unit UDI/GTIN: 10884389069745, Lot Number: 22IBM827,22HBW292; jjjjjjj. C-SECTION PACK, Item Number: OBP323G, Case UDI/GTIN: 40193489886413, Unit UDI/GTIN: 10193489886412, Lot Number: 22IBA633,22HBI799,22HBI800; kkkkkkk. C-SECTION PACK-LF, Item Number: PHS164410001, Case UDI/GTIN: 40889942035749, Unit UDI/GTIN: 10889942035748, Lot Number: 22IMG290; lllllll. PPH C-SECTION PACK-LF, Item Number: PHS322253008B, Case UDI/GTIN: 40193489636889, Unit UDI/GTIN: 10193489636888, Lot Number: 22IBN335; mmmmmmm. C SECTION PACK-LF, Item Number: PHS410129014C, Case UDI/GTIN: 40889942936961, Unit UDI/GTIN: 10889942936960, Lot Number: 22JBC784; nnnnnnn. C-SECTION PACK, Item Number: PHS774420G, Case UDI/GTIN: 40889942942511, Unit UDI/GTIN: 10889942942510, Lot Number: 22IMC958; ooooooo. C-SECTION PACK-LF, Item Number: PHS988341C, Case UDI/GTIN: 40889942484820, Unit UDI/GTIN: 10889942484829, Lot Number: 22IMH544

Quantity Affected: 11,886 cases (27,144 units)

Reason for Recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-11-17

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 163 device recalls issued in the same week, part of 413 device-related FDA actions this month.

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1092-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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