FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA device recall Z-1505-2013 · posted 2013-06-06 · Terminated
Recall details
- Recalling firm
- American Optisurgical Inc
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OJU
- Quantity affected
- 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.
- Date initiated
- 2013-04-30
- Date posted
- 2013-06-06
- Date terminated
- 2014-03-24
- Location
- Lake Forest, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.