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.
Enforcement
- Recall Number
- Z-0738-2017
- Event ID
- 75469
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- C.R. Bard, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 21, 2016
- Initiation Date
- August 3, 2016
- Classification Date
- December 12, 2016
- Termination Date
- October 5, 2021
- Address
- 8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States
Description
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.
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Product Code: 802065, Lot Numbers: NGZC4950, NGZD2121, NGZD4043, NGZD4876, NGZE2323, NGZE3389, NGZF0189, NGZF2494 and NGZF4014.
Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.