Nasopore Nasal Dressing Recall Due to Breached Sterile Packaging
Stryker Corporation is recalling Nasopore nasal dressings due to defects in blister seals that may compromise sterility. Affected products may have bubbles on the seal, indicating the sterile barrier has been breached.
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 recall involves sterile medical devices where the protective blister seal may be breached. No illnesses or injuries have been reported, placing this in the 'risk-of-harm product' category where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling Nasopore Ex Firm 4cm and Nasopore Forte plus 4cm fragmentable nasal dressings. A total of 182,344 units have been distributed nationwide in the United States.
The recalled products may have bubbles or imperfections on the blister seal. The blister seal is designed to act as a sterile barrier. When a bubble is present on the seal, it indicates that the sterility barrier has been breached.
Affected lot numbers for the 5400-030-004 model include 2024052333, 2023012514, 2023050514, 2023080912, and 2024020214. For the 5400-030-004ITL model, affected lot numbers include 2023071933, 2023102714, and 2024012314.
The recalled product
- Product
- Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Nasal Dressing
- Hazard
- sterile-barrier-breach
- defective-packaging
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 (4)
- 5400-030-004 UDI-DI: 07613154340835
- Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214
- 5400-030-004ITL UDI-DI: 07613327359442
- Lot Numbers: 2023071933 2023102714 2024012314
Distribution
Distributed nationwide across the United States.
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