Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-

Summary

The FDA issued a Class II for Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel by MEDLINE INDUSTRIES, LP - Northfield. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..

Details

Product Description

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810

Lot/Code Info: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC475, UPC Number: 10653160333081. b. Model Number: ECVC3900, UPC Number: 10653160334828. c. Model Number: STCVC20US, UPC Number: 10653160339076. d. Model Number: STCVC21US, UPC Number: 10653160339045. e. Model Number: ECVC6585A, UPC Number: 10653160338826. f. Model Number: ECVC7235A, UPC Number: 10653160354550. g. Model Number: STCVC03US, UPC Number: 10653160339212. h. Model Number: ECVC6655A, UPC Number:10653160339267. i. Model Number: ECVC7935, UPC Number: 10653160353669. j. Model Number: STCVC04US, UPC Number: 10653160339199. k. Model Number: ECVC7670, UPC Number:10653160348054. l. Model Number: ECVC7090, UPC Number: 10653160339243. m. Model Number: ECVC6930, UPC Number:10653160339250. n. Model Number: STCVC13US, UPC Number: 10653160339137. o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712. p. Model Number: ECVC8010, UPC Number: 10653160356356. q. Model Number: ECVC4615, UPC Number: 10653160336075. r. Model Number: DYNJ59184B, UPC Number: 019348994910. s. Model Number: DYNJ909267, UPC Number: 019532731461. t. Model Number: DYNJ906297D, UPC Number: 019532714128. u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222. v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047. w. Model Number: ECVC6665, UPC Number: 10653160337843. x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001. y. Model Number: DYNJ65481, UPC Number: 019348928046. z. Model Number: DYNJ60112B, UPC Number: 019532711884. aa. Model Number: DYNJ54755G, UPC Number: 019348998776; Model Number: DYNJ54755I, UPC Number: 019532702126. bb. Model Number: DYNJ0843244K, UPC Number: 019532728859. cc. Model Number: DYNJ57645C, UPC Number:019532728741. dd. Model Number: DYNJ46035C, UPC Number: 019348934095; Model Number: DYNJ46035D, UPC Number: 019348949364. ee. Model Number: DYNJ62007A, UPC Number: 019348987890. ff. Model Number: ECVC3665, UPC Number: 10653160336044. gg. Model Number: ECVC6190, UPC Number: 10653160337751. hh. Model Number: ECVC4380, UPC Number: 10653160338147. ii. Model Number: ECVC5655, UPC Number: 10653160337621. jj. Model Number: ECVC5650, UPC Number: 10653160336457. kk. Model Number: ECVC5660, UPC Number: 10653160337638. ll. Model Number: ECVC5685, UPC Number: 10653160337652. mm. Model Number: DYNJ0275614F, UPC Number: 088994217434. nn. Model Number: DYNJ43894B, UPC Number: 019348981048. oo. Model Number: DYNJ59307F, UPC Number: 019532705885. pp. Model Number: DYNJ58162, UPC Number: 088994282933. qq. Model Number: DYNJ51240A, UPC Number: 088994249352. rr. Model Number: ECVC3700, UPC Number: 10653160332886. ss. Model Number: ECVC4995, UPC Number: 10653160335283. tt. Model Number: ECVC5025, UPC Number: 10653160333142; Model Number: ECVC4135, UPC Number: 10653160335900. uu. Model Number: ECVC5820, UPC Number: 10653160338123. vv. Model Number: DYNJ65913, UPC Number: 019348930317. ww. Model Number: DYNJ41190, UPC Number: 088438989908; Model Number: DYNJ43894A, UPC Number: 088994213269; Model Number: DYNJ44087A, UPC Number: 088994256180; Model Number: DYNJ44524F, UPC Number: 019348946748; Model Number: DYNJ52806C, UPC Number: 019348929290. xx. Model Number: DYNJVB1000, UPC Number: 019348980099. yy. Model Number: DYNJ69742, UPC Number: 019348997490; Model Number: DYNJ69742B, UPC Number: 019532713688. zz. Model Number: ECVC2930, UPC Number: 10653160335368; Model Number: ECVC5835, UPC Number: 10653160333364. aaa. Model Number: DYNJ82030, UPC Number: 019532716237. bbb. Model Number: DYNJ82041, UPC Number: 019532716221. ccc. Model Number: DYNJ68729, UPC Number: 019348983654. ddd. Model Number: DYNJ38314G, UPC Number: 019348960334. eee. Model Number: DYNJ0416535AA, UPC Number: 019532735459; Model Number: DYNJ0416535W, UPC Number: 019348956435; Model Number: DYNJ0458661C, UPC Number: 088994255094. fff. Model Number: DYNJ0604508R, UPC Number: 019348982844. ggg. Model Number: DYNJ23288C, UPC Number: 019348995414. hhh. Model Number: DYNJ67136A, UPC Number: 019348993567. iii. Model Number: ECVC7465A, UPC Number: 10653160350088. jjj. Model Number: ECVC8100, UPC Number: 10653160357841. kkk. Model Number: DYNJ27613J, UPC Number: 019348956435; Model Number: DYNJ27613K, UPC Number: 019532713118. lll. Model Number: DYNJ80925, UPC Number: 019532708511. mmm. Model Number: DYNJ52425J, UPC Number: 019348994014. nnn. Model Number: DYNJ83251, UPC Number: 019532724865. ooo. Model Number: ECVC7310, UPC Number: 10653160345060; Model Number: ECVC7310A, UPC Number: 10653160352792. ppp. Model Number: ECVC2965, UPC Number: 10653160338611; Model Number: ECVC3155, UPC Number: 10653160334132; Model Number: ECVC5475, UPC Number: 10653160338116. qqq. Model Number: ECVC5015, UPC Number: 10653160338956. rrr. Model Number: ECVC3395, UPC Number: 10653160338635. sss. Model Number: ECVC5810, UPC Number: 10653160336419. ttt. Model Number: ECVC255, UPC Number: 10653160331735; Model Number: ECVC5200, UPC Number: 10653160336150. uuu. Model Number: ECVC825A, UPC Number: 10653160333548. vvv. Model Number: ECVC7180, UPC Number: 10653160343165. www. Model Number: ECVC7425, UPC Number: 10653160347699; Model Number: STCVC2040, UPC Number: 10653160336785; Model Number: STCVC2040A, UPC Number: 10653160345701. xxx. Model Number: ECVC7290, UPC Number: 10653160344933. yyy. Model Number: ECVC5355B, UPC Number: 10653160357742. zzz. Model Number: ECVC6020A, UPC Number: 10653160338413. aaaa. Model Number: ECVC1910, UPC Number:10653160334453; Model Number: ECVC5870A, UPC Number:10653160338383. bbbb. Model Number: ECVC6055A, UPC Number: 10653160335849. cccc. Model Number: ECVC6540, UPC Number: 10653160339397. dddd. Model Number: ECVC3735A, UPC Number: 10653160334798. eeee. Model Number: ECVC3355, UPC Number: 10653160333982; Model Number: ECVC3400, UPC Number: 10653160340591; Model Number: ECVC3460, UPC Number: 10653160332794; Model Number: ECVC3785, UPC Number: 10653160336006; Model Number: ECVC3810, UPC Number: 10653160336013; Model Number: ECVC4880, UPC Number: 10653160333111; Model Number: ECVC5020, UPC Number: 10653160334903; Model Number: ECVC5020A, UPC Number: 10653160358251; Model Number: ECVC5125, UPC Number: 10653160334934; Model Number: ECVC5270, UPC Number: 10653160336198; Model Number: ECVC6395, UPC Number: 10653160336372. ffff. Model Number: ECVC1490, UPC Number: 10653160332183; Model Number: ECVC1490A, UPC Number: 10653160359036; Model Number: ECVC1495, UPC Number: 10653160334569; Model Number: ECVC1495A, UPC Number: 10653160358794. gggg. Model Number: ECVC1710, UPC Number: 10653160332268. hhhh. Model Number: ECVC5815, UPC Number: 10653160336402. iiii. Model Number: DYNJ67990A, UPC Number: 019532726533. jjjj.Model Number: DYNJ41562F, UPC Number: 019348964108. kkkk. Model Number: DYNJ41562D, UPC Number: 019348958812. llll. Model Number: ECVC1655, UPC Number: 10653160254935. mmmm. Model Number: ECVC7170, UPC Number: 10653160333524. nnnn. Model Number: ECVC6680, UPC Number: 10653160337867; Model Number: ECVC6680A, UPC Number: 10653160337164. oooo. Model Number: ECVC6675, UPC Number: 10653160337850; Model Number: ECVC6675A, UPC Number: 10653160336617. pppp. Model Number: ECVC7970, UPC Number: 10653160353980. qqqq. Model Number: ECVC6815, UPC Number: 10653160335115. rrrr. Model Number: ECVC6840, UPC Number: 10653160336761. ssss. Model Number: ECVC6835, UPC Number: 10653160336778. tttt. Model Number: ECVC7485, UPC Number: 10653160354802. uuuu. Model Number: ECVC7615, UPC Number: 10653160348009; Model Number: ECVC7690, UPC Number: 10653160348153. vvvv. Model Number: ECVC6630, UPC Number: 10653160337492. wwww. Model Number: ECVC6690, UPC Number: 10653160336600. xxxx. Model Number: ECVC8135, UPC Number: 10653160358558; Model Number: ECVC8160, UPC Number: 10653160358404. yyyy. Model Number: ECVC7915, UPC Number: 10653160353355. zzzz. Model Number: ECVC6550, UPC Number: 10653160335276; Model Number: ECVC6595, UPC Number: 10653160337485; Model Number: ECVC7115B, UPC Number: 10653160350279; Model Number: ECVC7275, UPC Number: 10653160342700; Model Number: ECVC7275A, UPC Number: 10653160344292; Model Number: ECVC8015, UPC Number: 10653160355366. aaaaa. Model Number: ECVC7400, UPC Number: 10193489199956; Model Number: ECVC7960, UPC Number: 10653160353881; Model Number: ECVC8050, UPC Number: 10653160355601. bbbbb. Model Number: ECVC7945, UPC Number: 10653160353966. ccccc. Model Number: ECVC7625, UPC Number: 10653160356295. ddddd. Model Number: ECVC7895, UPC Number: 10653160355328. eeeee. Model Number: STCVC02US, UPC Number: 10653160336815; Model Number: STCVC02UST, UPC Number: 10653160358589. fffff. Model Number: ECVC7405, UPC Number: 10653160347132. ggggg. Model Number: ECVC7295, UPC Number: 10653160344650. hhhhh. Model Number: ECVC6765, UPC Number: 10653160336839. iiiii. Model Number: ECVC7495B, UPC Number: 10653160355748. jjjjj. Model Number: ECVC6505, UPC Number: 10653160336327; Model Number: ECVC7300, UPC Number: 10653160344698. kkkkk. Model Number: ECVC7560, UPC Number: 10653160347705; Model Number: ECVC7955, UPC Number: 10653160353867; Model Number: ECVC8020, UPC Number: 10653160355458; Model Number: ECVC8045, UPC Number: 10653160355595; Model Number: ECVC8085, UPC Number: 10653160356905. lllll. Model Number: ECVC8025, UPC Number: 10653160355434. mmmmm. Model Number: ECVC8040, UPC Number: 10653160355700. nnnnn. Model Number: ECVC7565, UPC Number: 10653160347682. ooooo. Model Number: ECVC7830A, UPC Number: 10653160355342. ppppp. Model Number: STCVC01US, UPC Number: 10653160336846; Model Number: STCVC01UST, UPC Number: 10653160358565. qqqqq. Model Number: ECVC7630, UPC Number: 10653160347750. rrrrr. Model Number: ECVC6050A, UPC Number: 10653160335894; Model Number: ECVC6670, UPC Number: 10653160336624; Model Number: ECVC7660, UPC Number: 10653160347804. sssss. Model Number: ECVC7385, UPC Number: 10653160346210; Model Number: ECVC7385A, UPC Number: 10653160347392; Model Number: ECVC7700, UPC Number: 10653160348375. ttttt. Model Number: ECVC5595, UPC Number: 10653160336495. uuuuu. Model Number: ECVC6800, UPC Number: 10653160335092. vvvvv. Model Number: ECVC7785, UPC Number: 10653160349365. wwwww. Model Number: ECVC6825A, UPC Number: 10653160336631. xxxxx. Model Number: ECVC7505A, UPC Number: 10653160352853. yyyyy. Model Number: ECVC7835A, UPC Number: 10653160355359. zzzzz. Model Number: ECVC8080, UPC Number: 10653160356899. aaaaaa. Model Number: STCVC06US, UPC Number: 10653160338314. bbbbbb. Model Number: ECVC1320, UPC Number: 10653160335795. cccccc. Model Number: ECVC6255, UPC Number: 10653160336525. dddddd. Model Number: ECVC6260, UPC Number: 10653160336488. eeeeee. Model Number: ECVC5080, UPC Number: 10653160337690. ffffff. Model Number: ECVC6920, UPC Number: 10653160336716; Model Number: ECVC7000, UPC Number: 10193489196399. gggggg. Model Number: ECVC6915, UPC Number: 10653160336723; Model Number: ECVC6975, UPC Number: 10653160336679. hhhhhh. Model Number: ECVC4105, UPC Number: 10653160334835. iiiiii. Model Number: ECVC6340A, UPC Number: 10653160355038. jjjjjj. Model Number: DYNJ0429121K, UPC Number: 019532706950. kkkkkk. Model Number: ECVC7330, UPC Number: 10653160345565.

Quantity Affected: 104,755 kits

Reason for Recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-15

Company