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MEDLINE recallZ-1455-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 23, 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

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

FDA root cause category: Process control

What the company is doing

Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.

Recall details

Recall number
Z-1455-2024
Status
Open, Classified
Initiated by the company
Feb 23, 2024
Posted by the FDA
Mar 29, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
0
Product code
LKB
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Product description

MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723

Code information (models, lots, serial numbers)

UDI/DI 20193489190844 (case)10193489190847 (each), Lot Numbers: 2023071290 (not distributed)

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94136).

Sources and updates

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