Class 2 Device Recall Sterile Procedural Trays

• Date Initiated by Firm: November 17, 2022
• Date Posted: February 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1092-2023
• Recall Event ID: 91386
• Product Classification: Cesarean section tray - Product Code OHM
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
• FDA Determined Cause: Device Design
• Action: Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
• Quantity in Commerce: 11,886 cases (27,144 units)
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.