[Recalled] 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 — The firm saw on the FDA web site a recall by the manufacturer of the Povidone I… |
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Custom Medical Specialties, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2351-2012 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 30 September 2011 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from Custom Medical Specialties, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.