Custom Vein Tray Recalled for Unverified Povidone Iodine Solution
Custom Medical Specialties is recalling Custom Vein Trays containing Povidone Iodine Prep Solution because the product lacked required microbial testing and failed specifications.
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 by the agency metadata, but the source text describes a quality control issue (lack of microbial testing) without reporting any illnesses or injuries. Per the rubric, this aligns with a voluntary precautionary recall or low-risk contamination where no harm has been reported, fitting the Moderate category.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 15 cases of CMS-8495-R5 Custom Vein Trays. These trays contain a 4-ounce bottle of PVP Prep Solution, which is used for skin preparation. The affected lots are identified by codes 15924-0906, 16975-0910, and 17709-0912.
The recall was initiated after the firm observed an FDA website notice regarding a recall of the Povidone Iodine Prep Solution by its manufacturer. The source text states that the product was recalled due to a lack of microbial testing and because it did not meet proper finished goods specifications.
The affected products were distributed nationwide in the United States, specifically including the states of Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania. Consumers and healthcare providers should stop using the affected trays and contact the recalling firm for further instructions.
The recalled product
- Product
- CMS-8495-R5 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
- 15
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)
- 15924-0906
- 16975-0910
- 17709-0912
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.
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