Device product
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Z-1505-2013
Product summary
- Event
- Event 65098
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63 individual applicators
- Official record key
device-enforcement:Z-1505-2013
Official wording
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.
Code information: Lot Numbers 07912-06 12912-04
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
lack of sterility