Food, drugs, devices › C.R. Bard, Inc.
Device recall: BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Sy
C.R. Bard, Inc. (Covington, GA) initiated this device recall on 3 Aug 2016; FDA lists 4 product records under event 75469, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 5 Oct 2021. Initiation: voluntary: firm initiated. C.R. Bard, Inc. has 49 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
C.R. Bard, Inc., Covington, GA.
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."
Distribution
"Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0735-2017 | 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… | 452,728 units | Class II | Terminated | 21 Dec 2016 |
| Z-0736-2017 | BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, 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… | — | Class II | Terminated | 21 Dec 2016 |
| Z-0737-2017 | 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… | — | Class II | Terminated | 21 Dec 2016 |
| Z-0738-2017 | 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… | — | Class II | Terminated | 21 Dec 2016 |
Context
Other enforcement events for C.R. Bard, Inc.
All 49 events for C.R. Bard, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Oct 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.