American Optisurgical Inc: Medical Device Recall in 2013 - (Recall #: Z-1505-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 30, 2013

Date Posted: June 12, 2013

Recall Number: Z-1505-2013

Event ID: 65098

Reason for Recall:

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.

Status: Terminated

Product Quantity: 63 individual applicators

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.

Voluntary or Mandated:

Voluntary: Firm initiated