MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures
MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 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 wound dressing is a potential harm and no injuries are reported.
Plain-English summary
The MediHoney Hydrogel dressing, model and catalog numbers 31620 and 31640, UDIs 10381780471370 and 10381780471400, is being recalled. The MediHoney Non-Adhesive Hydrogel Sheet Dressing is a moist wound dressing made with Leptospermum honey (+15). Affected lot numbers are listed in the recall notice. The recall covers 5,374 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 Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel…
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Care
- Affected units
- 5,374
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 (20)
- Model/Catalog Number: (1) 31620
- (2) 31640
- UDIs: (1) 10381780471370
- (2) 10381780471400
- Lot#s: (1) 30623
- 40724
- 25022
- 23823
- 54922
- 24123
- 54322
- 54023
- 23024
- 43823
- 13424
- (2) 24423
- 53424
- 11323
- 51324
- 10823
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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