Device product
TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO 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-1343-2015
Product summary
- Event
- Event 70721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32496 units
- Official record key
device-enforcement:Z-1343-2015
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: C9336, C9355, C10005, C10015, C10050, C10065, C10126, C10189, C10214, C10224, C10265, C10320, C11122, C11154, C11270, C11315, C11335, C12051, C12089, C12101, C12121, C12130, C12201, C12268, C12304, C13002, C13018, C13043, C13070, C13093, C13155, C13190, C13228, C13281, C14052, C14147, C14174, C14195.
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.