Peel-Away Introducer - Intended for the percutaneous recall: Sterility Concern
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and…
Why was Peel-Away Introducer - Intended for the percutaneous recalled?
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532
- Product
- Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and…
- Recalling firm
- Cook Incorporated
- Quantity
- 55 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
- Recall date
- April 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)