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Recall Observatory FDA recall evidence

Device product

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.

Z-1344-2015

March 10, 2015

Class II

Product summary

Firm
Microtek Medical Inc
Event
Event 70721
Status
Terminated
Classification
Class II
Quantity
30796 units
Official record key
device-enforcement:Z-1344-2015

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: C9344, C10091, C10158, C10214, C10221, C10257, C10264, C10298, C10342, C11060, C11104, C11118, C11136, C11180, C11216, C11237, C11290, C11313, C11334, C12060, C12096, C12180, C12206, C12235, C12243, C12334, C12355, C13008, C13032, C13042, C13053, C13067, C13128, C13179, C13212, C13248, C13281, C13303, C13317, C13338, C14036, C14057, C14121, C14140, C14169, C14183, C14197, C14233

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.