MediHoney wound gel recalled over potential packaging failures
Integra LifeSciences is recalling 49,367 units of MediHoney Gel with Active Leptospermum Honey over potential packaging failures that could breach the sterile barrier.
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: Scored 3 under the risk-of-harm criterion: the firm states packaging failures could breach the sterile barrier of a wound dressing, and no injuries are reported.
Plain-English summary
MediHoney Gel with Active Leptospermum Honey, model/catalog numbers 31805 and 31815, is being recalled by Integra LifeSciences Corp. (NeuroSciences). The record states the gel dressing provides a moist environment conducive to wound healing.
The reason given in the enforcement record is potential packaging failures, which could lead to a breach in the sterile barrier.
The record lists 49,367 units, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
A breach in the sterile barrier of a product applied to wounds carries an infection risk. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Integra's instructions.
The recalled product
- Product
- MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound dressing
- Affected units
- 49,367
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)
- 1. Model Number: 31805
- UDI-DI: 10381780486978
- Serial numbers: 2405
- 2406
- 2407
- 2408
- 2409
- 2410
- 2418
- 2419
- 2421
- 2422
- 2432
- 2433
- 2513
- 2514
- 2515. 2. Model Numbers: 31815
- UDI-DI: 10381780486886
- Lot Numbers: 2407
- 2425
Distribution
Part of a larger recall action
This product is one of 3 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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