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Recall Observatory FDA recall evidence

Device product

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.

Z-0163-2015

October 07, 2014

Class II

Product summary

Firm
C.R. Bard, Inc.
Event
Event 69462
Status
Terminated
Classification
Class II
Quantity
86 units
Official record key
device-enforcement:Z-0163-2015

Official wording

Reason: The product is non-sterile.

Code information: Product code: 042316, Lot number: BMXJM031

Distribution pattern: Worldwide Distribution in the states of AL, FL, NJ, NY, NC, PA, SC, TX, WI, and countries of Germany, Italy, Kuwait, and Luxembourg.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product is non-sterile.