Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
Custom Medical Specialties is recalling CMS-8450-R1 Custom Vein Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.
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 source text explicitly identifies the agency classification as Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 4 (Severe) or higher, as they represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 3 cases of CMS-8450-R1 Custom Vein Trays. These trays contain a 4 oz. bottle of PVP Prep Solution, which is used for skin preparation. The product was distributed nationwide, including in Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania.
The recall was initiated after the firm identified a recall by the manufacturer of the Povidone Iodine Prep Solution on the FDA website. The source text states that the Povidone Iodine Prep Solution was recalled due to a lack of microbial testing and because the product did not meet proper finished goods specifications.
The FDA has classified this as a Class I recall. Consumers and healthcare facilities should stop using the affected product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- CMS-8450-R1 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 Prep
- 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)
- 14161-0901
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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