Nasopore Ex Firm 4cm fragmentable nasal dressing recall: Sterility Concern
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Why was Nasopore Ex Firm 4cm fragmentable nasal dressing recalled?
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
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?
5400-030-004 UDI-DI: 07613154340835, Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214; 5400-030-004ITL UDI-DI: 07613327359442, Lot Numbers: 2023071933 2023102714 2024012314
- Product
- Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
- Recalling firm
- Stryker Corporation
- Quantity
- 182,344 total units
- Distribution
- US Nationwide distribution.
- Recall date
- April 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)