Custom Medical Specialties Recalls Amnio Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 7 cases of CMS-2586 Custom Amnio Trays containing a 2 oz. bottle of PVP Prep Solution. The product is used for skin preparation. The recall was initiated after the firm observed an FDA website notice regarding a recall of the Povidone Iodine Prep Solution component due to a lack of microbial testing and failure to meet proper finished goods specifications.
The affected products were distributed nationwide, including in Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania. The specific lot codes involved are 20144-1006 and 19702-1005.
Healthcare facilities and consumers should stop using the affected trays and contact Custom Medical Specialties, Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- CMS-2586 Custom Amnio Tray containing 2 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
- 7
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 (2)
- 20144-1006
- 19702-1005
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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