Z-1505-2013Class II

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

Name: Z-1505-2013 FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray
Creator: American Optisurgical Inc
Published: 2013-04-30
License: https://open.fda.gov/license/

Tenex Health / initiated 2013-04-30 / Terminated / root cause: manufacturing process

FDA source

American Optisurgical Inc began a recall of FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray on 2013-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1505-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-30
Posted: 2013-06-06
Terminated: 2014-03-24
Recalling firm: Tenex Health
Product: FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Product code: OJU Skin Prep Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 63 individual applicators
Distribution: 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.
Product codes and lots: Lot Numbers 07912-06 12912-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1505-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1505-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code OJU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)