Stryker Nasopore Nasal Dressing Recalled for Compromised Sterility Seals
Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units 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: FDA Class II medical device recall involving a compromised sterile barrier, which presents a risk of contamination and potential infection. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product without reported injury, meeting the High severity criterion.
Plain-English summary
Stryker Corporation is recalling Nasopore 8cm fragmentable nasal dressing with Catalog Numbers 5400-020-008 (Firm) and 5400-020-008ITL (Forte). A total of 182,344 units have been distributed nationwide in the United States across numerous lot numbers from 2022 through 2024.
The recall is being issued because the blister seals on the packaging may develop a bubble in the seal area. This seal is designed to maintain product sterility. When a bubble is present, it indicates that the sterile barrier has been breached and the product's sterility cannot be guaranteed.
Healthcare providers and patients with this product should consult with Stryker Corporation regarding the potential risk. The FDA classifies this as a Class II recall. Customers are advised to cease use of affected lot numbers and contact the manufacturer for instructions on return or replacement of the product.
The recalled product
- Product
- Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device
- 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)
- 5400-020-008 UDI-DI: 07613154340828
- 5400-020-008ITL UDI-DI: 07613327359428
Distribution
Distributed nationwide across the United States.
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