Recall Z-1505-2013— American Optisurgical Inc
Class II · Terminated
Class II FDA medical device recall by American Optisurgical Inc, initiated 2013-04-30, terminated 2014-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- American Optisurgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-30
- Terminated
- 2014-03-24
- Firm location
- Lake Forest, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.