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Recall Observatory FDA recall evidence

Device product

LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, 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-1348-2015

March 10, 2015

Class II

Product summary

Firm
Microtek Medical Inc
Event
Event 70721
Status
Terminated
Classification
Class II
Quantity
6540 units
Official record key
device-enforcement:Z-1348-2015

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: C10102, C10141, C10161, C10326, C10341, C11024, C11055, C11098, C11153, C11215, C11265, C11284, C11326, C11342, C12020, C12101, C12152, C12201, C12276, C12339, C13031, C13100, C13175, C13254, C13291, C14052

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.