Recall Z-1505-2013 ยท OJU Skin Prep Tray
American Optisurgical Inc
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
| Date | Jun 6, 2013 (initiated Apr 30, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | American Optisurgical Inc. sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL AND PRODUCT EXCHANGE" letter dated May 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-580-1266 for questions regarding this notice. |
| Quantity | 63 individual applicators |
| Distribution | Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.