MediHoney paste tubes recalled over packaging failures breaching the sterile barrier
MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.
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: 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 Tube, model and catalog numbers 31515 and 31535, UDIs 10381780486824 and 10381780486831, is being recalled. MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% active Leptospermum medical grade honey. Affected lot numbers are listed in the recall notice. The recall covers 141,620 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 ¿ 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)
- Category
- Medical Device — Wound Care
- Hazard
- sterility-compromise
- packaging-failure
- wound-dressing
- class-ii
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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