Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
- Company
- Stryker Corporation
- Recall Initiated
- February 25, 2025
- Posted
- March 28, 2025
- Recall Number
- Z-1481-2025
- Quantity
- 182,344 total units
- Firm Location
- Portage, MI
Reason for Recall
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.
Distribution
US Nationwide distribution.
Lot / Code Info
5400-212-004S UDI-DI: 07613154340842, Lot Numbers: 2024011914; 5400-222-004S UDI-DI: 07613327359473, Lot Numbers: 2024021212 2024052813
Root Cause
Under Investigation by firm
Action Taken
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 Instruments.Recalls@stryker.com. 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. Instruments.recalls@stryker.com. RESPONSE IS REQUIRED.