Z-1342-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- March 10, 2015
- Termination Date
- January 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 303 units
Product Description
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, 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.
Reason for Recall
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.
Distribution Pattern
US (nationwide) Distribution.
Code Information
Lot Numbers: C11020, C11129, C11238, C11276, C12013, C12044, C12079, C12094, C12108, C12124, C12212, C12236, C12243, C12254, C12271, C12334, C13031, C13070, C13080, C13162, C13168, C13189, C13205, C13254, C13294, C13345, C14020, C14055, C14072, C14120