Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Recall
- Recall Number
- Z-1480-2025
- Event Number
- 96393
- Firm
- Stryker Corporation
- FEI Number
- 3015967359
- Product Code
- NHB
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- February 25, 2025
- Posted
- March 28, 2025
- Address
- 1941 Stryker Way, Portage, MI, 49002-9711
Description
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
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.
An Urgent Medical Device Recall notification letter dated 2/24/25 was sent to customers. Actions to be taken 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email [email protected]. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. [email protected]. RESPONSE IS REQUIRED.
US Nationwide distribution.
182,344 total units