FDAClass IIApril 10, 2024

Centurion FCP Magill Cath 7.5 in PED recall: Sterility Concern

Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575

Why was Centurion FCP Magill Cath 7.5 in PED 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?

UDI/DI 00653160352054 (case), 10653160352051 (each), Lot Numbers: 2023071390

Product
Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
480 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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