Device product
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, 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-1345-2015
Product summary
- Event
- Event 70721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56904 units
- Official record key
device-enforcement:Z-1345-2015
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: C10147, C10166, C10169, C10174, C10196, C10201, C10207, C10210, C10236, C10298, C11067, C11089, C11108, C11194, C11208, C11238, C11271, C11311, C11362, C12009, C12020, C12032, C12034,C12058, C12081, C12118, C12165, C12187, C12214, C12228, C12303, C12333, C13014, C13050, C13072, C13214, C13282, C13291, C13322, C14090, C14209
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.