Skip to content
Recall Observatory FDA recall evidence

Device product

TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\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.

Z-1343-2015

March 10, 2015

Class II

Product summary

Firm
Microtek Medical Inc
Event
Event 70721
Status
Terminated
Classification
Class II
Quantity
32496 units
Official record key
device-enforcement:Z-1343-2015

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: C9336, C9355, C10005, C10015, C10050, C10065, C10126, C10189, C10214, C10224, C10265, C10320, C11122, C11154, C11270, C11315, C11335, C12051, C12089, C12101, C12121, C12130, C12201, C12268, C12304, C13002, C13018, C13043, C13070, C13093, C13155, C13190, C13228, C13281, C14052, C14147, C14174, C14195.

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.