Wound dressing recall due to potential sterile barrier packaging failures
Integra's MediHoney Hydrogel Adhesive Sheet dressings may have packaging failures compromising sterility. Affected units are being recalled worldwide.
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 recall without reported illnesses or injuries. The hazard—potential sterile barrier breach in a wound dressing—presents a risk of harm to patients, but no actual patient harm has been reported, placing this at Score 3 per the rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling MediHoney Hydrogel Adhesive Sheet wound dressings (Models 31722 and 31744) due to packaging failures that could compromise the sterile barrier. A total of 1,147 units have been identified with this defect.
The MediHoney dressings are used in wound care and contain Leptospermum honey in a hydrogel formula. A breach in the sterile barrier could allow contamination during storage or handling, potentially affecting the product's safety and efficacy for patients.
The recalled units were distributed worldwide, including across all 50 US states, Canada, Australia, New Zealand, South Korea, Guam, and Malaysia. Healthcare providers and patients should verify whether their dressings are from the affected lot numbers (Model 31722: lots 44422 and 14223; Model 31744: lots 50423 and 12523).
If you have one of these dressings, do not use it. Return it to your healthcare provider or contact Integra LifeSciences for replacement or refund.
The recalled product
- Product
- Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- sterile-barrier-breach
- packaging-defect
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 (8)
- Model/Catalog Numbers: (1) 31722
- (2) 31744
- UDIs - (1) 10381780471387
- (2) 10381780471394
- Lot #s: (1) 44422
- 14223
- (2) 50423
- 12523
Distribution
Distributed nationwide across the United States.
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