Medical wound dressing recalled for sterile packaging barrier failures
Integra LifeSciences is recalling MediHoney Paste, a medical wound dressing, due to packaging failures that could compromise the sterile barrier. The recall affects 15,441 units distributed worldwide.
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: This FDA Class II recall involves a confirmed packaging defect on a sterile medical device that could compromise the sterile barrier. With no reported illnesses or injuries, it meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' resulting in a High severity score.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling MediHoney Paste (Model 31505), a sterile medical wound dressing made of Active Leptospermum honey. Packaging failures have been identified that could compromise the sterile barrier of the product.
The recall affects 15,441 units distributed worldwide, including across all U.S. states and internationally in Canada, Australia, New Zealand, Korea, Guam, and Malaysia. The affected lot numbers include 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415, 2217, 2417, 2232, 2428, 2241, 2434, 2301, 2435, 2312, 2505, 2313, 2508, 2314, 2509, and 2328.
A compromised sterile barrier could allow contamination of the wound dressing. No injuries or illnesses related to this issue have been reported. Healthcare providers and patients should discontinue use of affected products and contact Integra LifeSciences for guidance on replacement or return procedures.
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 con
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Dressing
- Hazard
- packaging-defect
- sterile-barrier-breach
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
Distributed nationwide across the United States.
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