MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures
MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a breached sterile barrier on a wound dressing is a potential harm and no injuries are reported.
Plain-English summary
The MediHoney Hydrogel Adhesive Sheet, model and catalog numbers 31722 and 31744, UDIs 10381780471387 and 10381780471394, is being recalled. The dressing is a moist wound dressing made with Leptospermum honey. Affected lot numbers are listed in the recall notice. The recall covers 1,147 units distributed nationwide in the United States and internationally.
Packaging failures were identified which could lead to a breach in the sterile barrier. The FDA classified the action as Class II.
Hospitals, wound care clinics and other users holding affected lots should quarantine them and follow the manufacturer's instructions for return or replacement.
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)
- Category
- Medical Device — Wound Care
- Hazard
- sterility-compromise
- packaging-failure
- wound-dressing
- class-ii
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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