FDAClass IIFebruary 15, 2023

Sterile Procedural Trays recall

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.…

Why was Sterile Procedural Trays recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
11,886 cases (27,144 units)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Recall date
February 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls