Z-0163-2015Class II

Bard Dimension Stone Basket

Name: Z-0163-2015 Bard Dimension Stone Basket
Creator: C.R. Bard, Inc.
Published: 2014-10-07
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2014-10-07 / Terminated / root cause: sterility

FDA source

C.R. Bard, Inc. began a recall of 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... on 2014-10-07. FDA classified it as Class II and gives the reason as "The product is non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0163-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-07
Posted: 2014-10-31
Terminated: 2015-06-12
Recalling firm: C.R. Bard Inc
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.
Product code: FFL Dislodger, Stone, Basket, Ureteral, Metal
Reason for recall: The product is non-sterile.
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: Bard sent an Urgent: Medical Device Recall letter to each customer on 10/7/2014 with proof of delivery notice. Wholesalers were asked to conduct a sub-recall. Letter identify the affected product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine product subject to recall, do not use or further distribute any of the affected product, remove and return affected product to Bard Medical Division, and if the product have been further distributed identify your customers and notify them at once of the product recall. Customers were instructed to complete the enclosed Recall & Effectiveness Check Form and fax to 1-770-784-6469. For questions call 1-770-784-6471.
Quantity in commerce: 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.
Product codes and lots: Product code: 042316, Lot number: BMXJM031

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0163-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0163-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31

Product code FFL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)