Recall Z-0163-2015
C.R. Bard, Inc. · initiated October 7, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product code: 042316, Lot number: BMXJM031
Reason for recall
The product is non-sterile.
FDA-determined cause: Release of Material/Component prior to receiving test results
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.
Details
- Recall number
- Z-0163-2015
- Initiated
- October 7, 2014
- Posted by FDA
- October 31, 2014
- Terminated
- June 12, 2015
- Product code
- FFL – Dislodger, Stone, Basket, Ureteral, Metal
- Quantity
- 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.
- Recalling firm
- C.R. Bard, Inc., Covington, GA