Z-1470-2025Class II
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Stryker Corp. / initiated 2025-02-25 / Open, Classified / root cause: packaging
Stryker Corporation began a recall of Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL 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-1470-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Stryker Corp.
- Product
- Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
- 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
- 5400-010-004 UDI-DI: 07613154340798, Lot Numbers: 2022101814 2023021412 2023082413 2024022915 2022111414 2023051712 2023090114 2022102413 2023022133 2023090613 2024031915 2023011013 2023052415 2023110315 2022111413 2023050913 2023091912 2024032215 2023011913 2023061615 2023112314 2023011613 2023051213 2023103115 2024040214 2023020113 2023062132 2024011912 2023012413 2023071713 2023110812 2024052915 2023020333 2023062615 2024020813 2023012713 2023080812 2023112018 2024062412 2023020612 2023062915 2024080117 2023020912 2023081112 2024011613 2024080912 2023050414 2023070433 2024082216; 5400-010-004ITL UDI-DI: 07613327359435, Lot Numbers: 2022111414 2023051712 2023090114 2023011013 2023052415 2023110315 2023011913 2023061615 2023112314 2023020113 2023062132 2024011912 2023020333 2023062615 2024020813 2023020612 2023062915 2024080117 2023050414 2023070433 2024082216
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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