Microtek Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-1341-2015)
See the recall detail below. You can also see other recalls from the same firm in 2015.
LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO 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.
Class II
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.
Lot Numbers: C10104, C10272, C11080, C14052
US (nationwide) Distribution.
Voluntary: Firm initiated