Device product
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Z-0406-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 75492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75,089 units
- Official record key
device-enforcement:Z-0406-2017
Official wording
Reason: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Code information: Product Codes: REK32N and FEK32HW.
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Unknown
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.