Device product
BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, 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.
Z-0735-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 75469
- Status
- Terminated
- Classification
- Class II
- Quantity
- 452,728 units
- Official record key
device-enforcement:Z-0735-2017
Official wording
Reason: Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Code information: Product Code: 0038460, Lot Numbers: NGZC3768, NGZC5029, NGZD0924, NGZD1664, NGZD1983, NGZD3103, NGZD3241, NGZD3989, NGZD4053, GZD4923, NGZE1190, NGZE2134, NGZE3406, NGZF0305, NGZF1546, NGZF2589, NGZF3934, NGZF4488 and NGZF4885.
Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.
Derived failure modes
-
Labeling or packaging
Package Defect
-
Sterility assurance
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility