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Medline brand medical procedure convenience kits, labeled as recallZ-0177-2025 · 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-0177-2025
Status
Open, Classified
Initiated by the company
Sep 4, 2024
Posted by the FDA
Oct 23, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1506 units
Product code
OKV
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Product description

Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PACK, REF DYNJ42884; h) RFT D & C PACK, REF DYNJ50851; i) KIT OB, REF DYNJ906623; j) D AND C, REF DYNJ907957A; k) CHS OB PACK III, REF DYNJCH907

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

a) REF DYNJ0912449M, UDI/DI 40889942437536 (each), 10889942437535 (case), Lot Numbers: 23LBP185; b) REF DYNJ17309G, UDI/DI 40193489277181 (each), 10193489277180 (case), Lot Numbers: 24ABB399; c) REF DYNJ34268D, UDI/DI 40193489821421 (each), 10193489821420 (case), Lot Numbers: 23LBM844; d) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23LBS099; e) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23KBB869; f) REF DYNJ39668I, UDI/DI 40195327456284 (each), 10195327456283 (case), Lot Numbers: 23LBM868; g) REF DYNJ42884, UDI/DI 40888277011077 (each), 10888277011076 (case), Lot Numbers: 23KBB574; h) REF DYNJ50851, UDI/DI 40889942029014 (each), 10889942029013 (case), Lot Numbers: 23LBL975; i) REF DYNJ906623, UDI/DI 40193489794695 (each), 10193489794694 (case), Lot Numbers: 24ABE587; j) REF DYNJ907957A, UDI/DI 40195327189854 (each), 10195327189853 (case), Lot Numbers: 24BBA954; k) REF DYNJCH907, UDI/DI 40193489391979 (each), 10193489391978 (case), Lot Numbers: 24ABC904

Devices named in this recall

10 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