Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTH...
FDA Device Recall #Z-1127-2024 — Class I — November 15, 2023
Recall Summary
| Recall Number | Z-1127-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | November 15, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 14280 units |
Product Description
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
Reason for Recall
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.
Distribution Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Lot / Code Information
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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.