FDAClass IMarch 6, 2024

Medline Kits recall: Sterility Concern

MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT…

Why was Medline Kits recalled?

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

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) REF DYNJ65208A, UDI/DI 40195327120598 (case), 10195327120597 (unit), Lot Numbers: 23CMB532, 23CME753, 23EMD721, 23FMH948; b) REF DT22710, UDI/DI 40653160990636 (case), 10653160990635 (unit), Lot Numbers: c) REF DYNDC2002A, UDI/DI 21LBV542, 22CBM841, 22IBG132; d) REF DYNDC2723A, UDI/DI 40193489999236 (case), 10193489999235 (unit), Lot Numbers: 22ABH235, 22BBF113, 22IBG479; e) REF DYNDC2723B, UDI/DI 40195327007028 (case), 10195327004255 (unit), Lot Numbers: 22ABZ109, 22BBK108; f) REF CVI4805, UDI/DI 40195327068715 (case), 10195327068714 (unit), Lot Numbers: 22ABP582, 22CBP735, 22JBK237, 22LBK168; g) REF CVI4705, UDI/DI 40193489832373 (case), 10193489832372 (unit), Lot Numbers: 22CMF740, 22LMH493, 23BMA064, 23HMH653; h) REF DYNDC2721A, UDI/DI 40195327007080 (case), 10195327005313 (unit), Lot Numbers: 21LBK271, 22ABS686; i) REF DYNDC2721B, UDI/DI 40195327111091 (case), 10195327111090 (unit), Lot Numbers: 22CBS571, 22DBO302, 22IBG350; j) REF CVI4720, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23CLA574, 23DLA197; k) REF CVI4720A, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; l) REF CVI4720AH, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; m) REF DYNDA1584C, UDI/DI 40195327194506 (case), 10195327194505 (unit), Lot Numbers: 22HBB107, 22JBH444, 22KBN619, 22KBU753, 23ABH824, 23CBS036, 23EBD658, 23GBH542, 23IBI230; n) REF P155508D, UDI/DI 40193489899062 (case), 10193489899061 (unit), Lot Numbers: 22DMC487, 23AMB416, 23BMF491, 23FMD563; o) REF DT20345A, UDI/DI 40653160991565 (case), 10653160991564 (unit), Lot Numbers: 22ABJ804, 22BBA095, 22IBG184, 22OBE089; p) REF DYNDC2765B, UDI/DI 40195327039500 (case), 10195327039509 (unit), Lot Numbers: 22ABJ710, 22CBV307, 22CBX726, 22OBA248; q) REF DYNDC2004B, UDI/DI 40193489999335 (case), 10193489999334 (unit), Lot Numbers: 22ABH197, 22ABK671, 22BBE950, 22DBG182, 22GBD995; r) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; s) REF CVI4730H, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994, 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; t) REF DYNDC2927A, UDI/DI 40193489943420 (case), 10193489943429 (unit), Lot Numbers: 22BBW666, 22HBT170; u) REF DYNJ50717, UDI/DI 40889942032373 (case), 10889942032372 (unit), Lot Numbers: 22ABY200, 22HBH109; v) REF DYNDC2219B, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; w) REF DYNDC2219BH, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; x) REF CVI4395B, UDI/DI 40653160991633 (case), 10653160991632 (unit), Lot Numbers: 21LBV562, 22CBV268; y) REF DYNJ906907B, UDI/DI 40195327303526 (case), 10195327303525 (unit), Lot Numbers: 23BMF842; z) REF DT19740A, UDI/DI 40653160992524 (case), 10653160992523 (unit), Lot Numbers: 22EBE126, 22HBC049, 22IBG224; aa) REF DYNDH1636, UDI/DI 40193489934879 (case), 10193489934878 (unit), Lot Numbers: 22BBG415, 22DBE305, 22MBA761; bb) REF MNS13555, UDI/DI 40653160991954 (case). 10653160991953 (unit), Lot Numbers: 22CBE020, 22EBP942; cc) REF DYNJ64249A, UDI/DI 40193489381369 (case), 10193489381368 (unit), Lot Numbers: 22FLA161; dd) REF DYNDC2170, UDI/DI 40888277919100 (case), 10888277919099 (unit), Lot Numbers: 22HBO758, 22IBE630, 22LBP013, 23BBF471, 23BBL514, 23GBA859, 23JBD576; ee) REF DYNDC3251, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587; ff) REF DYNDC3251H, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587 gg) REF DYNDC3252, UDI/DI 40195327221141 (case), 10195327221140 (unit), Lot Numbers: 22IBG588; hh) REF DYNDA2142B, UDI/DI 40195327134168 (case), 10195327134167 (unit), Lot Numbers: 22DBG180, 22EMC030; ii) REF DYNDC2449B, UDI/DI 40195327010745 (case), 10195327010744 (unit), Lot Numbers: 21LBT939, 22EBP926, 22FBT224; jj) REF DYNDC3066, UDI/DI 40193489824644 (case), 10193489824643 (unit), Lot Numbers: 22CBD170; kk) REF DYNDC3103, UDI/DI 40193489962438 (case), 10193489962437 (unit), Lot Numbers: 22HBT222, 22IBG493, 22MBA063; ll) REF DYNDC3129A, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers: 22BBM598, 22CBZ667, 22DMC594, 22DME352; mm) REF DYNDC3129AH, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers: 22BBM598, 22CBZ667, 22DMC594, 22DME352; nn) REF DT19330B, UDI/DI 40653160992371 (case), 10653160992370 (unit), Lot Numbers: 22OBC582, 22OBE354; oo) REF DT22785, UDI/DI 40653160992326 (case), 10653160992325 (unit), Lot Numbers: 22CBP076, 22CBS504; pp) REF DT22780, UDI/DI 40653160992364 (case), 10653160992363 (unit), Lot Numbers: 22DBD209; qq) REF DYNDC1994C, UDI/DI 40195327083428 (case), 10195327083427 (unit), Lot Numbers: 22ABJ752, 22ABZ148, 22DBD308; rr) REF DYNDC1994D, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers: 22HBT161; ss) REF DYNDC1994DH, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers: 22HBT161; tt) REF DYNDC2555C, UDI/DI 40195327123421 (case), 10195327123420 (unit), Lot Numbers: 22OBE207; uu) REF DYNDV2480, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers: 22BMG253, 22CMF718, 22CMF720, 22GMB111; vv) REF DYNDV2480H, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers: 22BMG253, 22CMF718, 22CMF720, 22GMB111; ww) REF DYNDC2078, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers: 22EBV407, 22FBL375, 22GBF171; xx) REF DYNDC2078H, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers: 22EBV407, 22FBL375, 22GBF171; yy) REF DYNDC2657A, UDI/DI 40193489492973 (case), 10193489492972 (unit), Lot Numbers: 22FBU096, 22HBO094, 22IBT553, 23BBI094, 23EBD054, 23FBA804; zz) REF DYNDC3179, UDI/DI 40195327021444 (case), 10195327021443 (unit), Lot Numbers: 22ABK983, 22ABO532; aaa) REF DYNJ69976, UDI/DI 40195327000654 (case), 10195327001308 (unit), Lot Numbers: 22BBW440

Product
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Recall date
March 6, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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