Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model N

Summary

The FDA issued a Class II for Medline Convenience kits used for various procedures: 1) T A PACK, Model Numb by MEDLINE INDUSTRIES, LP - Northfield. Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits..

Details

Product Description

Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL PACK, Model Number: DYNJ44525C; 8) ENT TRAY, Model Number: DYNJ44391K; 9) ENT PACK, Model Number: DYNJ49300D; 10) NASAL PACK, Model Number: DYNJ61555B; 11) HEAD AND NECK, Model Number: DYNJ57287A; 12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F; 13) ENT PACK, Model Number: DYNJ54035B; 14) ENT PACK, Model Number: DYNJ36516; 15) FESS PACK, Model Number: DYNJ59502B; 16) T AND A PACK, Model Number: DYNJ80790; 17) PK,ENT, Model Number: DYNJ57583; 18) ENT/LAP PACK, Model Number: DYNJ84876; 19) TONSIL PACK, Model Number: DYNJ50109B; 20) TONSIL, Model Number: DYNJ908452C; 21) CSS SINUS PACK, Model Number: DYNJ17005I; 22) ENT, Model Number: DYNJ910514; 23) ADULT ENT - OAKBEND, Model Number: DYNJ905762; 24) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 25) ENT PACK, Model Number: DYNJ31453D; 26) ENT PACK, Model Number: DYNJ59447A; 27) TONSIL PACK, Model Number: DYNJ26441R; 28) ORAL ENT PACK, Model Number: DYNJ58408A; 29) ENT PACK, Model Number: DYNJ51085; 30) DR LANO NASAL CHRISTUS, Model Number: DYNJ61196A; 31) ENT PACK, Model Number: DYNJ66178D; 32) BWNBORO EENT PACK-LF, Model Number: DYNJ37551A; 33) HEAD AND NECK PACK, Model Number: DYNJ68872F; 34) EENT PACK, Model Number: DYNJ50301C; 35) ENT PACK, Model Number: DYNJ40498B; 36) SHN-C-THYROIDECTOMY-LF, Model Number: DYNJ46869A; 37) MINOR CYSTO PACK, Model Number: DYNJ58727D; 38) TONSILS AND ADENOIDS, Model Number: DYNJ45171C; 39) T&A PACK, Model Number: DYNJ56543J; 40) ENT PACK, Model Number: DYNJ54035B; 41) TONSIL PACK, Model Number: DYNJ50109B; 42) ENT PACK, Model Number: DYNJ40139D; 43) NASAL/SEPTO PACK, Model Number: DYNJ32099A; 44) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 45) ENT PACK, Model Number: DYNJ53573A; 46) CHS ENT PACK II, Model Number: DYNJCH908; 47) SIMPLE NECK DISSECTION, Model Number: DYNJ47481F; 48) TONSIL PACK, Model Number: DYNJ81479A; 49) E.N.T. TRAY, Model Number: DYNJ22357K; 50) NASAL PACK, Model Number: DYNJ39317B; 51) HEAD AND NECK PACK, Model Number: DYNJ54321D; 52) T A PACK, Model Number: DYNJ67791A; 53) ENT PACK, Model Number: DYNJ42451B; 54) HEAD AND NECK PACK-FOX, Model Number: DYNJ53348C; 55) HEAD AND NECK PACK, Model Number: DYNJ58596B; 56) SINUS PACK, Model Number: DYNJ56262; 57) ENT PACK, Model Number: DYNJ51085; 58) TONSIL T AND A PACK SHD, Model Number: DYNJ68417C; 59) ENT PACK, Model Number: DYNJ48595; 60) T AND A PACK-LF, Model Number: DYNJ52611; 61) HEAD AND NECK PACK, Model Number: DYNJ81897B; 62) ENSEMBLE ORL THYROIDE-LF, Model Number: DYNJ43390A; 63) EENT PACK-LF, Model Number: DYNJ34728D; 64) ENT, Model Number: DYNJ910514; 65) TONSIL ADENOID CKHA-LF, Model Number: DYNJ41771C; 66) ENT PACK, Model Number: DYNJ68679B; 67) PACK,T & A ASC, Model Number: DYNJ906914; 68) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 69) ENT PACK, Model Number: DYNJ83603; 70) ENT PACK, Model Number: DYNJ32247; 71) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 72) ENT PACK, Model Number: DYNJ31453D; 73) SINOSCOPY PACK-LF, Model Number: DYNJ25600L; 74) T & A PACK, Model Number: DYNJ38978C; 75) CSC-N T&A, Model Number: DYNJ50870D; 76) ENT I-LF, Model Number: DYNJS0702; 77) ENT KIT, Model Number: DYNJ902836F; 78) ENT PACK, Model Number: DYNJ66039B; 79) TONSIL CDS, Model Number: DYNJ907844D; 80) PACK,T & A ASC, Model Number: DYNJ906914

Lot/Code Info: 1) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24IBE758; 2) DYNJ66514, UDI-DI: 10193489359282(each), 40193489359283(case), Lot Number: 24IBE817; 3) DYNJ67775A, UDI-DI: 10193489996258(each), 40193489996259(case), Lot Number: 24IBG346; 4) DYNJ83158, UDI-DI: 10195327236885(each), 40195327236886(case), Lot Number: 24IBG449; 5) DYNJ0634878I, UDI-DI: 10195327694500(each), 40195327694501(case), Lot Number: 24IBG548; 6) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24IBG570; 7) DYNJ44525C, UDI-DI: 10193489232042(each), 40193489232043(case), Lot Number: 24IBG608; 8) DYNJ44391K, UDI-DI: 10195327457648(each), 40195327457649(case), Lot Number: 24IBG848; 9) DYNJ49300D, UDI-DI: 10193489297287(each), 40193489297288(case), Lot Number: 24IBH734; 10) DYNJ61555B, UDI-DI: 10195327608101(each), 40195327608102(case), Lot Number: 24IBH769; 11) DYNJ57287A, UDI-DI: 10193489854152(each), 40193489854153(case), Lot Number: 24IBH959; 12) DYNJ36720F, UDI-DI: 10198459079306(each), 40198459079307(case), Lot Number: 24IBQ081; 13) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24IBQ933; 14) DYNJ36516, UDI-DI: 10884389544112(each), 40884389544113(case), Lot Number: 24IBR105; 15) DYNJ59502B, UDI-DI: 10193489372939(each), 40193489372930(case), Lot Number: 24IBR121; 16) DYNJ80790, UDI-DI: 10195327079482(each), 40195327079483(case), Lot Number: 24IBR337; 17) DYNJ57583, UDI-DI: 10889942755332(each), 40889942755333(case), Lot Number: 24IBR873; 18) DYNJ84876, UDI-DI: 10195327431778(each), 40195327431779(case), Lot Number: 24IBR895; 19) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24IBS352; 20) DYNJ908452C, UDI-DI: 10195327610937(each), 40195327610938(case), Lot Number: 24JBD799; 21) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 24JBF130; 22) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24JBK654; 23) DYNJ905762, UDI-DI: 10193489507966(each), 40193489507967(case), Lot Number: 24JBK682; 24) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBK897; 25) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24JBM367; 26) DYNJ59447A, UDI-DI: 10193489707663(each), 40193489707664(case), Lot Number: 24JBM926; 27) DYNJ26441R, UDI-DI: 10198459085888(each), 40198459085889(case), Lot Number: 24JBN335; 28) DYNJ58408A, UDI-DI: 10889942969029(each), 40889942969020(case), Lot Number: 24JBN611; 29) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24JBN781; 30) DYNJ61196A, UDI-DI: 10195327604240(each), 40195327604241(case), Lot Number: 24JBN797; 31) DYNJ66178D, UDI-DI: 10198459100307(each), 40198459100308(case), Lot Number: 24JBN811; 32) DYNJ37551A, UDI-DI: 10888277585720(each), 40888277585721(case), Lot Number: 24JBT022; 33) DYNJ68872F, UDI-DI: 10198459079269(each), 40198459079260(case), Lot Number: 24JBT065; 34) DYNJ50301C, UDI-DI: 10198459052330(each), 40198459052331(case), Lot Number: 24JBT456; 35) DYNJ40498B, UDI-DI: 10193489806779(each), 40193489806770(case), Lot Number: 24JBV199; 36) DYNJ46869A, UDI-DI: 10198459069949(each), 40198459069940(case), Lot Number: 24JBV309; 37) DYNJ58727D, UDI-DI: 10198459048425(each), 40198459048426(case), Lot Number: 24JBV608; 38) DYNJ45171C, UDI-DI: 10889942485260(each), 40889942485261(case), Lot Number: 24JBV814; 39) DYNJ56543J, UDI-DI: 10195327453602(each), 40195327453603(case), Lot Number: 24JBW129; 40) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24JBW183; 41) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24JBW623; 42) DYNJ40139D, UDI-DI: 10195327663506(each), 40195327663507(case), Lot Number: 24JBX313; 43) DYNJ32099A, UDI-DI: 10195327610890(each), 40195327610891(case), Lot Number: 24JBY276; 44) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBY278; 45) DYNJ53573A, UDI-DI: 10193489201635(each), 40193489201636(case), Lot Number: 24JBY404; 46) DYNJCH908, UDI-DI: 10193489393347(each), 40193489393348(case), Lot Number: 24KBA907; 47) DYNJ47481F, UDI-DI: 10195327067335(each), 40195327067336(case), Lot Number: 24KBB421; 48) DYNJ81479A, UDI-DI: 10195327378370(each), 40195327378371(case), Lot Number: 24KBB455; 49) DYNJ22357K, UDI-DI: 10193489926736(each), 40193489926737(case), Lot Number: 24KBB793; 50) DYNJ39317B, UDI-DI: 10889942775729(each), 40889942775720(case), Lot Number: 24KBC590; 51) DYNJ54321D, UDI-DI: 10195327679323(each), 40195327679324(case), Lot Number: 24KBC663; 52) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24KBC754; 53) DYNJ42451B, UDI-DI: 10193489740318(each), 40193489740319(case), Lot Number: 24KBC910; 54) DYNJ53348C, UDI-DI: 10195327453565(each), 40195327453566(case), Lot Number: 24KBD155; 55) DYNJ58596B, UDI-DI: 10195327635947(each), 40195327635948(case), Lot Number: 24KBD243; 56) DYNJ56262, UDI-DI: 10889942624331(each), 40889942624332(case), Lot Number: 24KBD661; 57) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24KBE334; 58) DYNJ68417C, UDI-DI: 10195327341633(each), 40195327341634(case), Lot Number: 24KBE396; 59) DYNJ48595, UDI-DI: 10888277915183(each), 40888277915184(case), Lot Number: 24KBE590; 60) DYNJ52611, UDI-DI: 10889942300853(each), 40889942300854(case), Lot Number: 24KBF355; 61) DYNJ81897B, UDI-DI: 10198459155710(each), 40198459155711(case), Lot Number: 24KBF577; 62) DYNJ43390A, UDI-DI: 10889942670321(each), 40889942670322(case), Lot Number: 24KBG019; 63) DYNJ34728D, UDI-DI: 10198459061851(each), 40198459061852(case), Lot Number: 24KBG035; 64) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24KBG072; 65) DYNJ41771C, UDI-DI: 10889942599189(each), 40889942599180(case), Lot Number: 24KBG178; 66) DYNJ68679B, UDI-DI: 10195327129095(each), 40195327129096(case), Lot Number: 24KBG186; 67) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24KBG371; 68) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24KBG399; 69) DYNJ83603, UDI-DI: 10195327284886(each), 40195327284887(case), Lot Number: 24KBG953; 70) DYNJ32247, UDI-DI: 10884389203873(each), 40884389203874(case), Lot Number: 24KBG965; 71) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24KBG993; 72) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24KBG996; 73) DYNJ25600L, UDI-DI: 10889942686247(each), 40889942686248(case), Lot Number: 24KBH226; 74) DYNJ38978C, UDI-DI: 10195327583590(each), 40195327583591(case), Lot Number: 24KBH242; 75) DYNJ50870D, UDI-DI: 10195327165666(each), 40195327165667(case), Lot Number: 24KBH280; 76) DYNJS0702, UDI-DI: 10080196798728(each), 40080196798729(case), Lot Number: 24KBI176; 77) DYNJ902836F, UDI-DI: 10198459002816(each), 40198459002817(case), Lot Number: 24KBI638; 78) DYNJ66039B, UDI-DI: 10195327151997(each), 40195327151998(case), Lot Number: 24KBL783; 79) DYNJ907844D, UDI-DI: 10195327387334(each), 40195327387335(case), Lot Number: 24KBP945; 80) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24LBA080

Quantity Affected: 9216 units

Reason for Recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-03-03

Company