Z-1478-2025Class II
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm...
Stryker Corp. / initiated 2025-02-25 / Open, Classified / root cause: packaging
Stryker Corporation began a recall of Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1478-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Stryker Corp.
- Product
- Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
- Product code
- NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- 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.
- Root cause tag
- packaging
- FDA 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 [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.
- Quantity in commerce
- 182,344 total units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 5400-030-004 UDI-DI: 07613154340835, Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214; 5400-030-004ITL UDI-DI: 07613327359442, Lot Numbers: 2023071933 2023102714 2024012314
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1469-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1470-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1471-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1472-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1473-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1474-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1475-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1476-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1477-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1478-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1479-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1480-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1481-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1482-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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