MediHoney HCS Sheet Wound Dressing Recalled for Packaging Sterile Barrier Failures
Integra LifeSciences is recalling MediHoney HCS Sheet Dressing due to packaging failures that could compromise the sterile barrier and allow product contamination. The recall affects 3,583 units distributed 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: This is a Class II medical device recall involving a risk-of-harm product (wound dressing with compromised sterile barrier). No illnesses, injuries, or deaths are reported, and the hazard is theoretical (packaging 'could lead to' breach). Per the rubric, risk-of-harm products without reported injury score 3.
Plain-English summary
Integra LifeSciences Corp. is recalling MediHoney HCS Sheet Dressing with Leptospermum (model numbers 31612, 31622, 31644) due to identified packaging failures. The product is a sterile wound dressing made with Leptospermum Honey and a hydrogel colloid gelling agent designed to maintain a moist environment for optimal wound healing.
The packaging failures could lead to a breach in the sterile barrier. A compromised sterile barrier could allow the product to become contaminated, creating a risk when the dressing is applied to wounds.
The recall affects 3,583 units with the specified model numbers and affected lot numbers including D034323, 50623, 45022, 34023, 41223, 50423, 10323, 54223, and 42323. Distribution includes all U.S. states and territories as well as Canada, Australia, New Zealand, Korea, Guam, and Malaysia.
Healthcare facilities, hospitals, and individuals who have received this product should stop using it and contact Integra LifeSciences for instructions on return or replacement.
The recalled product
- Product
- Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination w
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Dressing
- Hazard
- sterile-barrier-breach
- product-contamination
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 (15)
- Model/Catalog Number: (1) 31612
- (2) 31622
- (3) 31644
- UDIs: (1) 10381780486947
- (2) 10381780471356
- (3) 10381780471363
- lot#s: (1) D034323
- (2) 50623
- 45022
- 34023
- (3) 41223
- 50423
- 10323
- 54223
- 42323
Distribution
Distributed nationwide across the United States.
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