MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures
MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 surgical dressing is a potential harm and no injuries are reported.
Plain-English summary
The MediHoney HCS Surgical Adhesive Sheet, model and catalog number 31738, UDI 10381780486961, lot 53824, is being recalled. The dressing is a moist wound dressing made with Leptospermum honey. The recall covers 4 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 and wound care clinics holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.
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 Care
- Affected units
- 4
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
Part of a larger recall action
This product is one of 8 recalled by Integra LifeSciences Corp. (NeuroSciences) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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