Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Reported: November 23, 2016 Initiated: October 13, 2016 #Z-0406-2017
Product Description
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Reason for Recall
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.
Details
- Recalling Firm
- C.R. Bard, Inc.
- Units Affected
- 75,089 units
- Distribution
- U.S. Nationwide.
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.. Recalled by C.R. Bard, Inc.. Units affected: 75,089 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0406-2017.
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