MediHoney Adhesive Hydrogel Dressing Recalled for Sterile Barrier Packaging Failure
Integra LifeSciences is recalling MediHoney Adhesive Hydrogel Dressing due to packaging failures that could breach the sterile barrier. The recall affects 994 units distributed in the US and internationally.
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 an FDA Class II recall for potential sterile barrier breaches due to packaging failures in a medical device designed for open wound care. The risk of contamination from a compromised sterile barrier qualifies this as a risk-of-harm product, meeting the criteria for High severity.
Plain-English summary
MediHoney Adhesive Hydrogel Sheet Dressing models 31720 and 31740, manufactured by Integra LifeSciences Corp., is being recalled due to packaging failures identified in the product. The dressing is a moist wound dressing made of Leptospermum Honey combined with a hydrogel gelling agent, designed for optimal wound healing and autolytic debridement.
The packaging failures could lead to a breach in the sterile barrier, which is a critical safety feature of this medical device. A compromised sterile barrier on a wound dressing increases the risk of contamination when applied to open wounds.
The recall affects 994 units with lot numbers 14422, 33324, 11524, and 10224 (model 31720) and lot numbers 23124 and 42423 (model 31740). The affected product was distributed worldwide, including throughout the US (all states), Canada, Australia, New Zealand, Korea, Guam, and Malaysia.
Healthcare providers and patients who have this product should discontinue use immediately and contact Integra LifeSciences Corp. for instructions on return or replacement.
The recalled product
- Product
- Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combinat
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Dressing
- Hazard
- sterile-barrier-breach
- 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 (10)
- Model/Catalog Numbers: (1) 31720
- (2) 31740
- UDIs: (1) 10381780471417
- (2) 10381780471424
- lot #s: (1) 14422
- 33324
- 11524
- 10224
- (2) 23124
- 42423
Distribution
Distributed nationwide across the United States.
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