FAST Procedure Kit. Intended for use as a Minor recall: Sterility Concern
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Why was FAST Procedure Kit. Intended for use as a Minor recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers 07912-06 12912-04
- Product
- FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
- Recalling firm
- American Optisurgical Inc
- 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.
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)