Recall Z-0404-2017— C.R. Bard, Inc.

Name: FDA recall Z-0404-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-13

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-10-13, terminated 2022-02-10. It names one FDA 510(k) clearance: K983498. Product: BARD INLAY Ureteral Stent with Suture, 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

1 on FDA's record

K983498 — BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STEC.R. Bard, Inc.·cleared 1998-12-15

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

BARD INLAY Ureteral Stent with Suture, 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.