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Recall Observatory FDA recall evidence

Device product

FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.

Z-1505-2013

April 30, 2013

Class II

Product summary

Firm
American Optisurgical Inc
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

    reason.labeling_packaging · v1.0.0

    incomplete seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of sterility