FDA Recall Terminated

BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

Recall: Z-0738-2017 · Initiated August 3, 2016

Recall

Recall Number: Z-0738-2017
Event Number: 75469
Firm: C.R. Bard, Inc.
FEI Number: 1018233
Product Code: KYZ
Status: Terminated
Root Cause: Process control
Initiated: August 3, 2016
Terminated: October 5, 2021
Address: 8195 Industrial Blvd NE, Covington, GA, 30014-1497

Description

Reason

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Action

BARD Medical sent an Urgent Medical Device Product Recall letter dated August 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine product subject to the recall. Complete and return the accompanying Recall & Effectiveness Check Form attached to the letter. If product was further distributed please identify those customers and notify them at once of the product recall by forwarding a copy of the letter. For questions regarding this recall call 770-784-6220.

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.