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Terminated

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

FDA Recall Z-1505-2013 · Posted 2013-06-06

Recalling FirmAmerican Optisurgical Inc
Recall StatusTerminated
Product CodeOJU
Date Initiated2013-04-30
Date Terminated2014-03-24
Product Quantity63 individual applicators

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.

Firm Action

American Optisurgical Inc. sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL AND PRODUCT EXCHANGE" letter dated May 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-580-1266 for questions regarding this notice.

Root Cause

Nonconforming Material/Component

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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