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Recall Observatory FDA recall evidence

Device product

Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX 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.

Z-1342-2015

March 10, 2015

Class II

Product summary

Firm
Microtek Medical Inc
Event
Event 70721
Status
Terminated
Classification
Class II
Quantity
303 units
Official record key
device-enforcement:Z-1342-2015

Official wording

Reason: 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.

Code information: Lot Numbers: C11020, C11129, C11238, C11276, C12013, C12044, C12079, C12094, C12108, C12124, C12212, C12236, C12243, C12254, C12271, C12334, C13031, C13070, C13080, C13162, C13168, C13189, C13205, C13254, C13294, C13345, C14020, C14055, C14072, C14120

Distribution pattern: US (nationwide) Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.