Custom Medical Specialties Recalls HSG Trays with Povidone Iodine Prep Solution
Custom Medical Specialties is recalling CMS-4501-R1 Custom HSG Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods 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, but the source text explicitly states no illnesses or injuries were reported and the hazard is theoretical (lack of testing/specifications), which limits the score to at most 3. Given the lack of reported harm and the specific nature of the defect, it is rated Moderate.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 5 cases of CMS-4501-R1 Custom HSG Trays. These trays contain a 2 oz. PVP Prep Bottle, where the PVP (Povidone Iodine) is used for skin preparation. The product was distributed nationwide in the United States, including 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 of the issue is that no microbial testing was in place at the manufacturer, and the product did not meet proper finished goods specifications.
The source text does not specify the actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the use of this product.
The recalled product
- Product
- CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle 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
- 5
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)
- 20182-1006
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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