FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: 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.
- Recall number
- Z-0735-2017
- Recalling firm
- C.R. Bard, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-08-03
- Posted
- not on file
- Terminated
- 2021-10-05
- 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 recall call 770-784-6220.
- Quantity
- 452,728 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYZ
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28