Medihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
Integra LifeSciences Corp. is recalling certain Medihoney Calcium Alginate dressings because packaging failures could lead to a breach in the sterile barrier.
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: The recall involves a medical device where a breach in the sterile barrier poses a high risk of harm, though no injuries have been reported.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling Medihoney Calcium Alginate with Active Leptospermum Honey dressings (Model Numbers 31012, 31022, and 31045).
The recall was initiated due to potential packaging failures that could result in a breach of the sterile barrier, which may compromise the product's sterility.
This recall affects approximately 55,276 units distributed worldwide, including in the United States and several other countries. Affected products include specific lot numbers for models 31012, 31022, and 31045.
The recalled product
- Product
- MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 55,276
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: 31012
- UDI-DI: 10381780486909
- Lot numbers: A24008
- A24057
- B21123
- B24075
- C22159
- C23177
- C24148
- D24190
- E21365
- E24254
- E24255
- G23393
- H21523
- H22452
- H23443
- I22512
- I23464
- J21693
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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