Device product
(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, 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-1347-2015
Product summary
- Event
- Event 70721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3180 units
- Official record key
device-enforcement:Z-1347-2015
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: C10042, C10062, C10099, C10133, C10188, C10264, C10327, C11207, C11221, C11285, C12006, C12019, C12083, C12114, C12135, C12157, C12207, C12347, C13011, C13086, C13126, C13144, C13260, C13289, C13340, C14037
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.