FAST Procedure Kit — Class II medical device recall Z-1505-2013
Terminated recall by American Optisurgical Inc, reported 2013-06-12, distributed nationwide. American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a su
| Recall number | Z-1505-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Optisurgical Inc, Lake Forest, CA, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 63 individual |
| Reason classes | sterility, packaging |
| Lot numbers | 07912-06, 12912-04 |
Product
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Reason for recall
American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
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-1505-2013. 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.