Nasopore FD nasal dressing recalled for potential sterile barrier breach
Stryker Corporation is recalling 182,344 units of Nasopore FD nasal dressing nationwide due to potentially breached sterile seals that may allow product contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a breached sterility barrier with no reported illnesses or injuries. The hazard is theoretical and risk-based, falling under the rubric criterion 'risk-of-harm products where injury has not yet been reported,' corresponding to Score 3.
Plain-English summary
Nasopore FD fragmentable nasal dressing (Catalog Numbers 5400-020-108 and 5400-020-108ITL) manufactured by Stryker Corporation is being recalled.
Stryker identified that blister seals on the packaging may develop bubbles in the seal area. The seal is designed to maintain product sterility; a bubble indicates the sterility barrier has been breached, potentially exposing the dressing to contamination.
The recall affects 182,344 units distributed nationwide in the United States. Affected product can be identified by specific lot numbers and UDI-DI codes provided by the manufacturer.
Patients and healthcare providers should contact Stryker Corporation for information about affected units and next steps.
The recalled product
- Product
- Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Nasal Dressing
- Hazard
- sterile-barrier-breach
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 5400-020-108 UDI-DI: 07613327117226
- 5400-020-108ITL UDI-DI: 07613327117226
Distribution
Distributed nationwide across the United States.
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