Medical device wound dressing recalled due to packaging failures compromising sterile barrier
Integra LifeSciences is recalling MediHoney wound dressing tubes due to packaging failures that could compromise the sterile barrier. The recall affects approximately 141,620 units distributed nationwide and internationally.
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: FDA Class II device with identified packaging failures that could compromise the sterile barrier of a wound dressing. This is a risk-of-harm product where injury has not yet been reported, meeting the criterion for a High severity rating.
Plain-English summary
Integra LifeSciences Corp. is recalling MediHoney Tube wound dressings (models 31515 and 31535) due to identified packaging failures that could compromise the sterile barrier. MediHoney is a moist wound dressing composed of 100% Active Leptospermum medical grade honey used to maintain a moist environment conducive to wound healing.
The identified packaging failures could allow the sterile barrier to be breached, potentially compromising the sterile integrity of the product.
Approximately 141,620 units have been distributed. The recall affects all U.S. states and includes distribution to Canada, Australia, New Zealand, Korea, Guam, and Malaysia. Affected lot numbers for model 31515 include: 2123, 2211, 2124, 2212, 2127, 2213, 2128, 2222, 2129, 2223, 2132, 2232, 2133, 2233, 2137, 2243, 2136, 2244, 2143, 2309, 2150, 2307, 2210. For model 31535: 2108, 2242, 2116, 2306, 2123, 2313, 2124, 2315, 2138, 2333, 2139, 2339, 2201, 2404, 2209, 2423, 2213.
Healthcare providers and consumers should stop using affected products and contact Integra LifeSciences or their healthcare provider for guidance on replacement products.
The recalled product
- Product
- Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 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 envir
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- packaging-failure
- 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: (1) 31515 and (2) 31535
- UDI - (1) 10381780486824
- (2) 10381780486831
- lot#s: (1) 2123
- 2211
- 2124
- 2212
- 2127
- 2213
- 2128
- 2222
- 2129
- 2223
- 2132
- 2232
- 2133
- 2233
- 2137
- 2243
- 2136
Distribution
Distributed nationwide across the United States.
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