CVS honey wound pads recalled over packaging failures breaching sterile barrier
CVS Honey Pads, catalog numbers 9370613 and 937404, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 111,492 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
The CVS Honey Pad, model and catalog numbers CVS9370613 and CVS937404, is being recalled. The product is a wound pad infused with natural medical-grade Manuka (Leptospermum) honey. Affected lot numbers are listed in the recall notice. The recall covers 111,492 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.
Anyone holding affected product should stop using it and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found…
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Care
- Affected units
- 111,492
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 (10)
- Model/Catalog Numbers: (1) CVS9370613
- (2) CVS937404 UDIs: (1) 00050428510377*
- (2) 0050428462584* (* UDI owned by CVS) Lot#s: (1) 024622
- (2) 014622
- 044622
- 020923
- 040923
- 054623
- 020124
- 014524
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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