Reported Jun 12, 2013 · Terminated
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
American Optisurgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Optisurgical Inc · 26902 Vista Ter · Lake Forest, CA · 92630-8123
Is this the product you have?
- FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
- Lot codes and dates
- Lot Numbers 07912-06 12912-04
- Amount recalled
- 63 individual applicators
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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