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U.S. Department of Health and Human Services

Class 2 Device Recall BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only

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  Class 2 Device Recall BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only see related information
Date Initiated by Firm August 03, 2016
Create Date December 12, 2016
Recall Status1 Terminated 3 on October 05, 2021
Recall Number Z-0738-2017
Recall Event ID 75469
Product Classification Syringe, irrigating (non dental) - Product Code KYZ
Product 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.
Code Information Product Code: 802065, Lot Numbers: NGZC4950, NGZD2121, NGZD4043, NGZD4876, NGZE2323, NGZE3389, NGZF0189, NGZF2494 and NGZF4014.
Recalling Firm/
C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Michael Wolfe
Manufacturer Reason
for Recall
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
FDA Determined
Cause 2
Process control
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.