Reported Apr 8, 2015 · Terminated
LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended use:…
Microtek Medical 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: Microtek Medical Inc · 602 N Lehmberg Rd · Columbus, MS · 39702-4406
Is this the product you have?
LASER RESISTANT WAND - STERILE7/8" X 8" (2.22cm x 20.32cm)REF 24013QTY 10 EASTERILE EO
- NO LATEX Intended useThe smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites
- Lot codes and dates
- Lot Numbers
C10102C10141C10161C10326C10341C11024C11055C11098C11153C11215C11265C11284C11326C11342C12020C12101C12152C12201C12276C12339C13031C13100C13175C13254C13291C14052
- Lot Numbers
- Amount recalled
- 6540 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
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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