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Medline procedure kits labeled as recallZ-1435-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 11, 2025

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

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583

Recall details

Recall number
Z-1435-2025
Status
Open, Classified
Initiated by the company
Feb 11, 2025
Posted by the FDA
Mar 25, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
340 units
Product code
OFT
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749

Code information (models, lots, serial numbers)

1) Pack Number DYNJRA0869A, 10889942531059 (each) 40889942531050 (case), Lot Number 20KBD382A; 2) Pack Number DYNJRA1749, 10193489829273 (each) 40193489829274 (case), Lot Number 24CMF477A

Devices named in this recall

2 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 96374).

Sources and updates

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