Surgical Wound Dressing Recalled Due to Packaging Defect
Integra LifeSciences is recalling MediHoney HCS Surgical Adhesive Sheets due to packaging failures that could compromise the product's sterile barrier.
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 recall involves a risk-of-harm medical device where a compromised sterile barrier could lead to contamination. No illnesses or injuries have been reported. The FDA Class II classification combined with the absence of reported harm places this at Score 3 per the rubric (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Integra LifeSciences Corp. is recalling MediHoney HCS Surgical Adhesive Sheets (Model 31738, Lot 53824) due to identified packaging failures that could lead to breaches in the product's sterile barrier.
MediHoney HCS Surgical Adhesive Sheets are moist wound dressings used for post-operative and acute wound management. The product consists of Leptospermum Honey combined with a hydrogel colloidal gelling agent in an adhesive dressing form. A compromised sterile barrier could allow contamination during storage or handling.
The affected product was distributed nationwide across all 50 U.S. states and internationally to Canada, Australia, New Zealand, Korea, Guam, and Malaysia. The recalled lot is limited to Lot 53824.
Healthcare providers and patients currently using this product should stop use and contact Integra LifeSciences for guidance on obtaining replacement products. Unused product should be isolated and returned to the manufacturer.
The recalled product
- Product
- Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Dressing
- Hazard
- sterile-barrier-compromise
- 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)
- Model/Catalog Number: 31738
- UDI- 10381780486961
- Lot # 53824
Distribution
Distributed nationwide across the United States.
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