Hemopore nasal wound dressing packaging seal defect may compromise sterility
Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate 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 is a Class II FDA recall for a medical device with a potential sterility seal breach. No illnesses or injuries have been reported, and the hazard is theoretical. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Stryker Corporation has issued a recall for 182,344 units of Hemopore 8cm nasal/sinus temporary wound dressing (Catalog Numbers 5400-020-208 and 5400-020-208ITL). The products affected were distributed nationwide in the United States.
The blister seals on these products may develop a bubble on the seal area of the packaging. The packaging seal acts as a sterile barrier, and a bubble indicates that the sterility seal may have been breached, potentially allowing contamination of the device.
Healthcare providers and patients using affected lot numbers should discontinue use. Contact Stryker Corporation with questions about returns or replacements. If you have concerns about exposure to a potentially non-sterile device, consult your healthcare provider.
The recalled product
- Product
- Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Wound Dressing
- Hazard
- sterility-breach
- packaging-defect
- contamination-risk
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 (3)
- 5400-020-208 UDI-DI: 07613327117233
- 5400-020-208ITL UDI-DI: 07613327602623
- Lot Numbers: 2024052333
Distribution
Distributed nationwide across the United States.
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