FDA Device recall Z-1505-2013
FAST Procedure Kit
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of FAST Procedure Kit by American Optisurgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1505-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-30 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Optisurgical |
| Distribution | US |
Product
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Reason
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.
Identifiers
| code_info | Lot Numbers 07912-06 12912-04 |
|---|
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-1505-2013%22
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