CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV… — Class II medical device recall Z-2329-2012
Terminated recall by Custom Medical Specialties, Inc., reported 2012-09-19, distributed nationwide. The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manu
| Recall number | Z-2329-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Medical Specialties, Inc., Pine Level, NC, United States |
| Recall initiated | 2011-09-30 |
| Classified | 2012-09-07 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2012-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 16 cases |
| Reason classes | microbial contamination |
Product
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2329-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.