Recall Z-1477-2025 ยท NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Stryker Corporation
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
| Date | Mar 28, 2025 (initiated Feb 25, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 182,344 total units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070715 | NASOPORE EAR Polyganics B.V.,, May 7, 2007 |