FDAFDA · Food and drugs·Recall number Z-1505-2013
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Published June 12, 2013 · Recall initiated: April 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Optisurgical Inc
- Distributor
- 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.
- Lot
- Lot Numbers 07912-06 12912-04
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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