Recall Z-0737-2017
C.R. Bard, Inc. · initiated August 3, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BARD Piston Syringe, 60cc, 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.
Codes / lots: Product Code: 750375, Lot Numbers: NGZC4960, NGZD3108, NGZE1244, NGZE3556 and NGZF2584.
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: Process control
Action taken
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.
Details
- Recall number
- Z-0737-2017
- Initiated
- August 3, 2016
- Terminated
- October 5, 2021
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.
- Recalling firm
- C.R. Bard, Inc., Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0735-2017 Class II | BARD Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | 08/03/2016Terminated |
| Z-0736-2017 Class II | BARD 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | 08/03/2016Terminated |
| Z-0738-2017 Class II | BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | 08/03/2016Terminated |