Custom Vein Tray Recalled for Missing Microbial Testing
Custom Medical Specialties is recalling CMS-4316 Custom Vein Trays because the included PVP Prep Solution lacked required microbial testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard is a lack of microbial testing rather than a confirmed contamination or reported illness, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 6 cases of CMS-4316 Custom Vein Trays. These trays contain a 4 oz. bottle of PVP Prep Solution used for skin preparation. The recall was initiated after the firm observed a related recall by the manufacturer of the Povidone Iodine Prep Solution.
The reason for the recall is that the PVP Prep Solution did not undergo required microbial testing and did not meet proper finished goods specifications. The affected products were distributed nationwide in the United States, specifically in Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania.
The affected lot codes are 15287-0905, 15974-0906, and 17052-0910. Consumers and healthcare facilities should check their inventory for these specific lot codes and stop using the product if it matches the recalled items.
The recalled product
- Product
- CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Surgical Trays
- Affected units
- 6
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 (3)
- 15287-0905
- 15974-0906
- 17052-0910
Distribution
Part of a larger recall action
This product is one of 12 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.
See all 12 products in this recall →Related recalls
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