FDAClass IIApril 10, 2024

Centurion hook kits labeled as: a) STERILE SKIN HOOK recall: Sterility Concern

Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code…

Why was Centurion hook kits labeled as: a) STERILE SKIN HOOK 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) 66660, UDI/DI 60653160052154 (case) 00653160052152 (each), Lot Numbers: 2023042790, 2023091190; b) 67105, UDI/DI 60653160061880 (case) 00653160061888 (each), Lot Numbers: 2023042690; c) 67810, UDI/DI 30653160196703 (case) 00653160196702 (each), Lot Numbers: 2023060790, 2023070790; d) I68655, UDI/DI 00653160317220 (case) 10653160317227 (each), Lot Numbers: 2023061290

Product
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1520 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)
Open FDA enforcement record Latest recalls