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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications."
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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