FDAFDA · Food and drugs·Recall number Z-0406-2017
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Published November 23, 2016 · Recall initiated: October 13, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- C.R. Bard, Inc.
- Distributor
- U.S. Nationwide.
- Lot
- Product Codes: REK32N and FEK32HW.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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