Device product
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.
Z-1346-2015
Product summary
- Event
- Event 70721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5889 units
- Official record key
device-enforcement:Z-1346-2015
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: 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
Distribution pattern: US (nationwide) Distribution.
Derived failure modes
-
Unknown
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.