MEDLINE INDUSTRIES, LP - Northfield: 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

Recall number

Z-1127-2024

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

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

Status

Open, Classified

Initiated

2023-11-15

Posted

2024-02-25

Terminated

not on file

Reason

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.

Root cause

Nonconforming Material/Component

Action

MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Quantity

14280 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

OJH

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy