Z-0738-2017Class II

BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available in a single use...

Name: Z-0738-2017 BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available in a single use...
Creator: C.R. Bard, Inc.
Published: 2016-08-03
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-08-03 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc. began a recall of 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... on 2016-08-03. FDA classified it as Class II and gives the reason as "Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0738-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-03
Posted: 2016-12-12
Terminated: 2021-10-05
Recalling firm: C.R. Bard Inc
Product: 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.
Product code: KYZ Syringe, Irrigating (Non Dental)
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.
Root cause tag: manufacturing process
FDA 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 recall call 770-784-6220.
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.
Product codes and lots: Product Code: 802065, Lot Numbers: NGZC4950, NGZD2121, NGZD4043, NGZD4876, NGZE2323, NGZE3389, NGZF0189, NGZF2494 and NGZF4014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0738-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0735-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12
Z-0736-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12
Z-0737-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12
Z-0738-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12

Product code KYZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)