Nasal dressing recall: potential sterile barrier breach from seal defect
Stryker is recalling over 182,000 Nasopore nasal dressings due to potential bubbles in the blister seal that could compromise the sterile barrier. The affected units were distributed nationwide.
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 medical device recall involves a product with a critical sterile-barrier function. Although no illnesses or injuries have been reported, the manufacturing defect represents a risk-of-harm situation—a compromised sterile barrier on a surgical nasal dressing poses a potential contamination risk. Per the rubric, when no illnesses/injuries are reported but the hazard is theoretical, the maximum score is 3.
Plain-English summary
Stryker Corporation is recalling approximately 182,344 units of Nasopore Ex Firm 8cm and Nasopore Forte plus 8cm fragmentable nasal dressings. These products were distributed nationwide.
The recall is due to a potential manufacturing defect in the blister seals used to package these products. Bubbles may develop on the seal surface. These seals function as a critical sterile barrier; a bubble on the seal indicates the sterility of the device has been compromised.
Multiple lot numbers across both product types are included in this recall. Affected lot numbers are specified in the FDA recall notice.
The recalled product
- Product
- Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Wound Dressing
- Hazard
- seal-defect
- sterility-breach
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)
- 5400-030-008 UDI-DI: 07613154340842
- 5400-030-008ITL UDI-DI: 07613327359473
Distribution
Distributed nationwide across the United States.
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