Custom Medical Specialties Recalls PVP Prep Solution Due to Lack of Microbial Testing
Custom Medical Specialties is recalling PVP Prep Solution kits because the manufacturer did not perform required microbial testing, meaning the product may not meet specifications.
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: The recall involves a medical device where the lack of microbial testing creates a risk of harm (infection) that has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 4 cases of the CMS-4219-R2 Custom Laser Pack, which contains 2 oz bottles of PVP Prep Solution. The product is used for skin preparation. The recall was initiated after the firm observed a manufacturer recall on the FDA website indicating that no microbial testing was in place at the manufacturing facility. Consequently, the product did not meet proper finished goods specifications.
The affected product was distributed nationwide, including in Georgia, Michigan, New York, and Pennsylvania. The specific code for the recalled items is 20179-1006.
Consumers and healthcare facilities should stop using the product and contact Custom Medical Specialties, Inc. for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Affected units
- 4
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)
- 20179-1006
Distribution
Part of a larger recall action
This product is one of 4 recalled by Custom Medical Specialties, Inc. 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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