PlainRecalls
FDA Devices Moderate Class II Terminated

BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, 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 irr

Reported: December 21, 2016 Initiated: August 3, 2016 #Z-0736-2017

Product Description

BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, 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.

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.

Details

Recalling Firm
C.R. Bard, Inc.
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, 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.. Recalled by C.R. Bard, Inc..
Why was this product recalled?
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 21, 2016. Severity: Moderate. Recall number: Z-0736-2017.