MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-1127-2024)

Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F; g) EXTREMITY IV, REF CMPJ06040D; h) EXTREMITY IV, REF CMPJ06040F; i) EXTREMITY PROCEDURE, REF CDS981656I; j) FACIAL PLASTY PACK, REF DYNJ55335D; k) FOOT PROCEDURE, REF CDS981659I; l) FOOT PROCEDURE, REF CDS981659J; m) HAND, REF DYNJ902002J; n) HAND PACK, REF DYNJ35744A; o) HAND PACK, REF DYNJ68873C; p) HAND PACK, REF DYNJ46211K; q) KNEE ARTHROSCOPY CDS, REF CDS941004C; r) KNEE PACK, REF DYNJ68512; s) LACERATION TRAY, REF SUT21580; t) LOWER EXTREMITY, REF DYNJ907121F; u) LOWER EXTREMITY, REF DYNJ46222M; v) LOWER EXTREMITY PACK, REF DYNJ67216C; w) LOWER EXTREMITY PACK, REF DYNJ67216D; x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892; y) PODIATRY PACK, REF DYNJ68347A; z) PODIATRY PACK, REF DYNJ68347B; aa) PODIATRY PACK-LF, REF DYNJ34648D; bb) POSTERIOR PACK, REF DYNJ64576A; cc) SHOULDER, REF DYNJ903011J; dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G; ee) SHOULDER KIT, REF DYNJ907705D; ff) SMALL HAND CDS, REF DYNJ902002G; gg) SMALL HAND CDS, REF DYNJ902002I; hh) SMALL HAND PACK, REF CMPJ06038F; ii) SMALL HAND PACK, REF CMPJ06038G; jj) TOTAL KNEE, REF DYNJ909159; kk) TOTAL KNEE CDS, REF CDS982823P; ll) TOTAL KNEE CDS, REF CDS982823Q; mm) TRIGGER FINGER KIT, REF DYNJ68406; nn) UPPER EXTREMITY, REF DYNJ907130C

Class I

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.

a) REF DYNJ64814A, UDI/DI 40195327112807 (case), 10195327112806 (unit), Lot Numbers: 22FBD779, 22JBN895; b) REF DYNDH1629, UDI/DI 40193489917360 (case), 10193489917369 (unit), Lot Numbers: 22ABP606; c) REF DYNJ48587A, UDI/DI 40889942313106 (case), 10889942313105 (unit), Lot Numbers: 22JBQ342, 23ABL345, 23CBJ954, 23DBK384, 23FBQ607; d) REF CDS983313I, UDI/DI 40193489424540 (case), 10193489424539 (unit), Lot Numbers: 22DDA444, 22EDB075, 23ADB093, 23CDC442, 23DDA819, 23EDC367; e) REF DYNJ902004D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers: 22FBR327, 22JBQ099; f) REF DYNJ902004F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers: 23BBF818, 23BBN981, 23HBL676, 23IBA162, 23IBJ945; g) REF CMPJ06040D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers: 22EBU873, 22IBA206; h) REF CMPJ06040F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers: 23ABN951, 23ABU853, 23GBV583, 23GBW733, 23HBK120; i) REF CDS981656I, UDI/DI 40193489433884 (case), 10193489433883 (unit), Lot Numbers: 22BDB050, 22EDB527, 22FDB578, 23BDA698, 23BDB738, 23EDA039; j) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers: 23JBB690; k) REF CDS981659I, UDI/DI 40193489433907 (case), 10193489433906 (unit), Lot Numbers: 23BDB207, 23DDA594, 23EDA040, 23FDB570; l) REF CDS981659J, UDI/DI 40195327398508 (case), 10195327398507 (unit), Lot Numbers: 23JBM035; m) REF DYNJ902002J, UDI/DI 40195327516070 (case), 10195327516079 (unit), Lot Numbers: 22DBB588, 23DBA171, 23EBL341, 23FBA124, 23FBU113, 23FBV329, 23GBN600, 23GBQ956, 23JBA529; n) REF DYNJ35744A, UDI/DI 40889942600596 (case), 10889942600595 (unit), Lot Numbers: 22DBB588; o) REF DYNJ68873C, UDI/DI 40195327375691 (case), 10195327375690 (unit), Lot Numbers: 23FBA124, 23FBU113, 23FBV329, 23GBQ956; p) REF DYNJ46211K, UDI/DI 40195327407484 (case), 10195327407483 (unit), Lot Numbers: 23DBA171, 23EBL341, 23GBN600, 23JBA529; q) REF CDS941004C, UDI/DI 40888277507471 (case), 10888277507470 (unit), Lot Numbers: 22ALA255, 22IMA552; r) REF DYNJ68512, UDI/DI 40193489828956 (case), 10193489828955 (unit), Lot Numbers: 21KBI896, 22BBV355, 22EBN387, 22EBP166, 22FBA911, 22FBL484, 22IBO503, 22JBW455, 22KBM697, 22LBN605, 22LBQ786, 23BBB214, 23BBS153, 23EBO560, 23GBN713, 23HBH102, 23JBL709; s) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers: 23EBL458; t) REF DYNJ907121F, UDI/DI 40195327222087 (case), 10195327222086 (unit), Lot Numbers: 22LBR588; u) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23HBP767, 23IBW177; v) REF DYNJ67216C, UDI/DI 40195327280674 (case), 10195327280673 (unit), Lot Numbers: 22LLA847, 23CLA146; w) REF DYNJ67216D, UDI/DI 40195327405183 (case), 10195327405182 (unit), Lot Numbers: 23ELA164, 23FLA372; x) REF DYNJ906892, UDI/DI 40193489281461 (case), 10193489281460 (unit), Lot Numbers: 22GBI467, 22GBM602, 22OBH187, 22OBJ425, 22OBK650; y) REF DYNJ68347A, UDI/DI 40193489934107 (case), 10193489934106 (unit), Lot Numbers: 22ABK059, 22BBU107, 22CBS838; z) REF DYNJ68347B, UDI/DI 40195327141197 (case), 10195327141196 (unit), Lot Numbers: 22FBG492, 22FBU866; aa) REF DYNJ34648D, UDI/DI 40193489916165 (case), 10193489916164 (unit), Lot Numbers: 22HBH536; bb) REF DYNJ64576A, UDI/DI 40195327111954 (case), 10195327111953 (unit), Lot Numbers: 22GBL600; cc) REF DYNJ903011J, UDI/DI 40195327437573 (case), 10195327437572 (unit), Lot Numbers: 23IBF175, 23JBS067; dd) REF CDS981658G, UDI/DI 40193489876827 (case), 10193489876826 (unit), Lot Numbers: 22CDC277, 23DDB287; ee) REF DYNJ907705D, UDI/DI 40195327375783 (case), 10195327375782 (unit), Lot Numbers: 23EBU785, 23JBF717, 23KBA709; ff) REF DYNJ902002G, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers: 22HBA403, 22HBS428, 22IBE726; gg) REF DYNJ902002I, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers: 22LBS865, 23ABO144, 23BBR667, 23DBS266, 23EBT050, 23FBE713, 23HBQ460; hh) REF CMPJ06038F, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers: 22EBI104, 22HBO484; ii) REF CMPJ06038G, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers: 22KBG879, 22KBU962, 23BBD874, 23DBA902, 23DBK147, 23EBQ126, 23GBQ295; jj) REF DYNJ909159, UDI/DI 40195327280896 (case), 10195327280895 (unit), Lot Numbers: 23EBS908; kk) REF CDS982823P, UDI/DI 40193489402760 (case), 10193489402759 (unit), Lot Numbers: 22OBI091; ll) REF CDS982823Q, UDI/DI 40195327238340 (case), 10195327238339 (unit), Lot Numbers: 23ABT038, 23BBK666, 23EBJ570, 23FBL610, 23HBE191, 23JBD296, 23JBR325; mm) REF DYNJ68406, UDI/DI 40193489440363 (case), 10193489440362 (unit), Lot Numbers: 22OBK988; nn) REF DYNJ907130C, UDI/DI 40193489821636 (case), 10193489821635 (unit), Lot Numbers: 23ABD199

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Voluntary: Firm initiated