Z-1479-2025Class II
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm...
Stryker Corp. / initiated 2025-02-25 / Open, Classified / root cause: packaging
Stryker Corporation began a recall of Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL 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-1479-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Stryker Corp.
- Product
- Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
- 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
- 5400-030-008 UDI-DI: 07613154340842, Lot Numbers: 2023012515 2023012715 2023022012 2023050814 2023072632 2023102312 2023102612 2024032514 2024040212; 5400-030-008ITL UDI-DI: 07613327359473, Lot Numbers: 2022092714 2023020633 2023032433 2023050915 2023052514 2023062216 2023082814 2023101112 2024031812 2022092914 2023020814 2023032814 2023051114 2023053115 2023062032 2023090618 2023101714 2024042212 2022101332 2023020915 2023033016 2023051215 2023060914 2023082215 2023100312 2023102014 2024042312 2022121932 2023021416 2023050115 2023052214 2023061412 2023082312 2023100412 2024030414 2024061814 2022122032 2023022032 2023050515 2023052412 2023061514 2023082514 2023100912 2024030512 2024062814
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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