PlainRecalls
FDA Devices Moderate Class II Terminated

Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.

Reported: November 12, 2014 Initiated: October 7, 2014 #Z-0163-2015

Product Description

Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.

Reason for Recall

The product is non-sterile.

Details

Recalling Firm
C.R. Bard, Inc.
Units Affected
86 units
Distribution
Worldwide Distribution in the states of AL, FL, NJ, NY, NC, PA, SC, TX, WI, and countries of Germany, Italy, Kuwait, and Luxembourg.
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.. Recalled by C.R. Bard, Inc.. Units affected: 86 units.
Why was this product recalled?
The product is non-sterile.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 12, 2014. Severity: Moderate. Recall number: Z-0163-2015.