FDAClass IIOctober 30, 2024

Centurion brand recall: Sterility Concern

Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY

Why was Centurion brand 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) UDI/DI 40653160270929 (each), 10653160270928 (case), Lot Numbers: 23LBO858; b) UDI/DI 40653160284346 (each), 10653160284345 (case), Lot Numbers: 23LBL653

Product
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
168 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Recall date
October 30, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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