FDA Device recall Z-2352-2012
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 p…
- FDA Device
- Class I
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class I recall of 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 p… by Custom Medical Specialties, citing 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 speci….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2352-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2011-09-30 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Custom Medical Specialties |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | 14161-0901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2352-2012%22
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