Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
FDA Recall Z-1474-2025 · Posted 2025-03-28
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Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeNHB
Date Initiated2025-02-25
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.
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 [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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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