Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability

FDA device recall Z-0163-2015 · posted 2014-10-31 · Terminated

Recall details

Recalling firm

C.R. Bard, Inc.

Reason for recall

The product is non-sterile.

Action taken

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.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

FFL

Quantity 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.

Date initiated

2014-10-07

Date posted

2014-10-31

Date terminated

2015-06-12

Location

Covington, GA