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.
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 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 ge
- 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 (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
Distributed nationwide across the United States.
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