Reported Apr 8, 2015 · Terminated
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended…
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?
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm)WITH TUBING EXTENDERSTERILEREF 24010QTY 24\CS
- STERILE EO 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
C10147C10166C10169C10174C10196C10201C10207C10210C10236C10298C11067C11089C11108C11194C11208C11238C11271C11311C11362C12009C12020C12032C12034C12058C12081C12118C12165C12187C12214C12228C12303C12333C13014C13050C13072C13214C13282C13291C13322C14090C14209
- Lot Numbers
- Amount recalled
- 56904 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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