FDA-Device2013-06-12Class II
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
American Optisurgical Inc
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.
Sold states
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.
Affected count
63 individual applicators
Manufactured in
26902 Vista Ter, N/A, Lake Forest, CA, United States
Products
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1505-2013Don't want to check this manually?
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