FDAClass IIApril 10, 2024

Centurion retractor kits labeled as: a) STERILE 6-1/2" recall: Sterility Concern

Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code…

Why was Centurion retractor kits labeled as: a) STERILE 6-1/2" 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.

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) 66795, UDI/DI 50653160061180 (case) 00653160061185 (each), Lot Numbers: 2023030190, 2023052390, 2023092590; b) 67525, UDI/DI 10653160158639 (case) 00653160158632 (ease), Lot Numbers: 2023032490; c) 37535, UDI/DI 10653160169048 (case) 00653160169041 (each), Lot Numbers: 2023061490

Product
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
760 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Recall date
April 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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