CMS-2586 Custom Amnio Tray containing 2 oz — Class I medical device recall Z-2353-2012
Terminated recall by Custom Medical Specialties, Inc., reported 2012-09-26, distributed nationwide. The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no m
| Recall number | Z-2353-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Medical Specialties, Inc., Pine Level, NC, United States |
| Recall initiated | 2011-09-30 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 7 cases |
| Reason classes | microbial contamination |
Product
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP 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 of the Povidone Iodine Prep Solution due to no microbial testing 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-2353-2012. 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.