MediHoney paste tubes 31505 recalled over packaging failures affecting sterility
MediHoney Paste, catalog number 31505, is recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 15,441 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
MediHoney Paste, model and catalog number 31505, UDI 10381780486930, is being recalled. MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% active Leptospermum medical grade honey. Affected lot numbers include 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415 and 2217, with the full list in the recall notice. The recall covers 15,441 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¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment…
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Care
- Affected units
- 15,441
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: 31505
- UDI: 10381780486930
- Lot #s: 2150
- 2336
- 2151
- 2337
- 2201
- 2414
- 2209
- 2415
- 2217
- 2417
- 2232
- 2428
- 2241
- 2434
- 2301
- 2435
- 2312
- 2505
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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