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Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code… recallZ-1429-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 23, 2024

Class II Open, Classified All recalls posted in March 2024

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-1429-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Feb 23, 2024
Posted by the FDA
Mar 29, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
100 units
Product code
OFX
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Product description

Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6

Code information (models, lots, serial numbers)

UDI/DI 10653160129257 (case), 00653160129250 (each), Lot Numbers: 2023022290, 2023042490

Devices named in this recall

1 device 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 94136).

Sources and updates

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