Recall Z-0738-2017 ยท KYZ Syringe, Irrigating (Non Dental)
C.R. Bard, Inc.
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 cathe
| Date | Aug 3, 2016 |
| Status | Terminated |
| Reason | Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. |
| Root cause | 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 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.