FDA Device recall Z-2349-2012
CMS-4501-R1 Custom HSG Tray containing 2 oz
- FDA Device
- Class I
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class I recall of CMS-4501-R1 Custom HSG Tray containing 2 oz 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 in place at the manufacturer and product did not mee….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2349-2012 |
| 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-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
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 in place at the manufacturer and product did not meet proper finished goods specifications.
Identifiers
| code_info | 20182-1006 |
|---|
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-2349-2012%22
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