FDAFDA · Food and drugs·Recall number Z-1344-2015
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.
Published April 8, 2015 · Recall initiated: March 10, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microtek Medical Inc
- Distributor
- US (nationwide) Distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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