Recall Z-0406-2017— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-10-13, terminated 2022-02-10. It names 2 FDA 510(k) clearances: K043193, K983498. Product: Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.. 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..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-13
- Terminated
- 2022-02-10
- Firm location
- Covington, GA, United States
510(k) clearances named in this recall
2 on FDA's record- K043193 — BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
- K983498 — BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.