Z-1476-2025Class II
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Stryker Corp. / initiated 2025-02-25 / Open, Classified / root cause: packaging
Stryker Corporation began a recall of Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL 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-1476-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Stryker Corp.
- Product
- Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
- 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
- 5400-020-108 UDI-DI: 07613327117226, Lot Numbers: 2023011317 2023021717 2023030932 2023040317 2023083017 2023102517 2024020517 2024080717; 5400-020-108ITL UDI-DI: 07613327117226, Lot Numbers: 2023012017 2023032817 2023042017 2023091117 2023111417 2023120517 2024011817 2023020732 2023041117 2023062017 2023092017 2023112017 2024010817 2024012417 2023031717 2023041417 2023082317 2023103117 2023112817 2024011217
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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