Microtek Medical product recalled over sterility concerns

Recall date

March 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Microtek Medical Inc recalls VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and ac…

Recall number

Z-1344-2015

FDA classification

Class II

Brand / firm

Microtek Medical Inc

Sold / distributed

US (nationwide) Distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The 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.