Surgical ophthalmic wicks recalled for potential effectiveness loss
McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.
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: This is an FDA Class II recall of a surgical ophthalmic device with no reported illnesses or injuries. The hazard—potential loss of product effectiveness from temperature exposure—is theoretical. Per the rubric, recalls with theoretical hazards and no reported harm are at most High (3).
Plain-English summary
McKesson Medical-Surgical Inc. Corporate Office is recalling Beaver-Visitec International Ultracell Wick (catalog #30316-C), a surgical ophthalmic device. The recall affects 3 boxes distributed nationwide.
The manufacturing facility experienced temperature excursions between June and August 2021 prior to product delivery. Exposure to higher temperatures during storage may have impacted the product's effectiveness.
All lots of this product received between June 1 and September 30, 2021 are affected by this recall. The product was distributed to healthcare providers nationwide.
Healthcare providers and organizations with this product should stop use and contact McKesson Medical-Surgical Inc. for return or replacement instructions. No illnesses or injuries have been reported.
The recalled product
- Product
- BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 3
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 (1)
- Not Available
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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