TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, 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.
Enforcement
- Recall Number
- Z-1346-2015
- Event ID
- 70721
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Microtek Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2015
- Initiation Date
- March 10, 2015
- Classification Date
- March 27, 2015
- Termination Date
- January 21, 2017
- Address
- 602 N Lehmberg Rd, N/A, Columbus, MS, 39702-4406, United States
Description
TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, 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.
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.
Lot Numbers: C9225, C9232, C10239, C10285, C11042, C11129, C11136, C11172, C11209, C11216, C11279, C11300, C11332, C12010, C12023, C12102, C12157, C12194, C12215, C12251, C12290, C12339, C12348, C13008, C13056, C13057, C13092, C13157, C13164, C13176, C13268, C13295, C13308, C13337, C13340, C14027, C14057, C14094, C14135, C14195, C14209 C14232, C14238
US (nationwide) Distribution.
5889 units