Nasopore 4cm Standard 2PK fragmentable nasal dressing recall: Sterility Concern
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Why was Nasopore 4cm Standard 2PK 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?
5400-212-004S UDI-DI: 07613327500387, Lot Numbers: 2024011914; 5400-222-004S UDI-DI: 07613327500479, Lot Numbers: 2024021212 2024052813
- Product
- Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
- 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)