—#130716

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.

FDA product code: FFL — Dislodger, Stone, Basket, Ureteral, Metal
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Product code: 042316, Lot number: BMXJM031

Why it was recalled

The product is non-sterile.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

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.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

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.

Timeline

Recall initiated: 2014-10-07
Posted by FDA: 2014-10-31
Terminated: 2015-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130716. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.