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Medline brand medical procedure convenience kits, labeled as recallZ-0179-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Sep 4, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.

Recall details

Recall number
Z-0179-2025
Status
Open, Classified
Initiated by the company
Sep 4, 2024
Posted by the FDA
Oct 23, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
2371 units
Product code
OJH
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Product description

Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B; 8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B; 9) CVL INSERTION KIT-LF, REF DYNJ48587A; 10) CVL INSERTION KIT-LF, REF DYNJ48587A; 11) ENSEMBLE SURPLUS LCA-LF, REF DYNJ48892C; 12) EXTREMITY PACK, REF DYNJ49301B; 13) ACL ACCESSORY PACK, REF DYNJ50952F; 14) SPINAL INJECTION PACK, REF DYNJ51383F; 15) FTMC ARTHROS BASIC SETUP-LF, REF DYNJ54602A; 16) MINOR EXTREMITY PACK, REF DYNJ55324G; 17) MINOR EXTREMITY PACK, REF DYNJ55324G; 18) D-SPINE SUPPLEMENT PACK, REF DYNJ58115A; 19) EXTREMITY PACK, REF DYNJ62877; 20) AHT LG KNEE ROLL, REF DYNJ64823; 21) CUSTOM ORTHO PACK, REF DYNJ83675; 22) DR SUNDAR SCS KIT, REF DYNJ85288A; 23) CENTRAL SCS TRIAL PACK, REF DYNJ85503; 24) TOTAL KNEE CDS-LF, REF DYNJ909569; 25) EXTREMITY PACK, REF SYNJ10253B; 26) CARROLLTON HIP FX, REF SYNJ910003A; 27) ARTHROSCOPY, REF SYNJ910004C

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

1) REF CDS982519W, UDI/DI 40195327389971 (each), 10195327389970 (case), Lot Numbers: 24BBQ775; 2) REF CDS984003A, UDI/DI 40888277002891 (each), 10888277002890 (case), Lot Numbers: 24ABG354; 3) REF DYNJ32639C, UDI/DI 40889942919223 (each), 10889942919222 (case), Lot Numbers: 23KBE944; 4) REF DYNJ39547B, UDI/DI 40193489760485 (each), 10193489760484 (case), Lot Numbers: 23LBO506; 5) REF DYNJ41229C, UDI/DI 40195327609727 (each), 10195327609726 (case), Lot Numbers: 24ABK563; 6) REF DYNJ45153B, UDI/DI 40195327235414 (each), 10195327235413 (case), Lot Numbers: 24ABD667; 7) REF DYNJ46719B, UDI/DI 40889942279303 (each), 10889942279302 (case), Lot Numbers: 23LBP194; 8) REF DYNJ46739B, UDI/DI 40889942314318 (each), 10889942314317 (case), Lot Numbers: 24ABG221; 9) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23LBO732; 10) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23KBO606; 11) REF DYNJ48892C, UDI/DI 40889942791768 (each), 10889942791767 (case), Lot Numbers: 23KBB893; 12) REF DYNJ49301B, UDI/DI 40889942686613 (each), 10889942686612 (case), Lot Numbers: 24ABB592; 13) REF DYNJ50952F, UDI/DI 40193489361668 (each), 10193489361667 (case), Lot Numbers: 23LBV189; 14) REF DYNJ51383F, UDI/DI 40193489225588 (each), 10193489225587 (case), Lot Numbers: 23LBS071; 15) REF DYNJ54602A, UDI/DI 40195327456673 (each), 10195327456672 (case), Lot Numbers: 23LBO084; 16) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23LBL961; 17) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23KBE137; 18) REF DYNJ58115A, UDI/DI 40195327582037 (each), 10195327582036 (case), Lot Numbers: 23LBL852; 19) REF DYNJ62877, UDI/DI 40193489695824 (each), 10193489695823 (case), Lot Numbers: 23LBV377; 20) REF DYNJ64823, UDI/DI 40193489221054 (each), 10193489221053 (case), Lot Numbers: 23LBK801; 21) REF DYNJ83675, UDI/DI 40195327296408 (each), 10195327296407 (case), Lot Numbers: 24ABG702; 22) REF DYNJ85288A, UDI/DI 40195327543083 (each), 10195327543082 (case), Lot Numbers: 24ABG603; 23) REF DYNJ85503, UDI/DI 40195327509904 (each), 10195327509903 (case), Lot Numbers: 23LBS030; 24) REF DYNJ909569, UDI/DI 40195327399703 (each), 10195327399702 (case), Lot Numbers: 24BBF009; 25) REF SYNJ10253B, UDI/DI 40193489373593 (each), 10193489373592 (case), Lot Numbers: 24ABG182; 26) REF SYNJ910003A, UDI/DI 40889942848448 (each), 10889942848447 (case), Lot Numbers: 24ABW931; 27) REF SYNJ910004C, UDI/DI 40195327246748 (each), 10195327246747 (case), Lot Numbers: 24BBC876

Devices named in this recall

25 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95415).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page