FDA Medical Device Recalls (openFDA)
American Optisurgical Inc: FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
- Recall number
- Z-1505-2013
- Recalling firm
- American Optisurgical Inc
- Product
- FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
- Status
- Terminated
- Initiated
- 2013-04-30
- Posted
- 2013-06-06
- Terminated
- 2014-03-24
- 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.
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers 07912-06 12912-04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJU
- Firm FEI
- 1000135560
- Firm city
- Lake Forest
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28