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American Optisurgical Inc recalls FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Recalled June 12, 2013 · FDA recall Z-1505-2013 · American Optisurgical
Hazard
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. · FDA Class II
Units
63 individual applicators
Sold at
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.
Description
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.
Product
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Manufacturer(s)
American Optisurgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →