FDA Device recall Z-2331-2012
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution by Custom Medical Specialties, citing the firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2331-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-30 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Custom Medical Specialties |
| Distribution | US |
Product
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Reason
The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Identifiers
| code_info | 14327-0902, 19929-1006 |
|---|
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-2331-2012%22
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