Food, drugs, devices › C.R. Bard, Inc.
Device recall: Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological us
C.R. Bard, Inc. (Covington, GA) initiated this device recall on 11 Jan 2021; FDA lists 1 product record under event 87163, 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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 2 Feb 2023. 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
"The device catheter tip was cut off (no tip) and the product packaging was not fully sealed."
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1431-2021 | Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only. | 9,800 Units | Class II | Terminated | 28 Apr 2021 |
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: "The device catheter tip was cut off (no tip) and the product packaging was not fully sealed."
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 distribution and the countries of Australia, Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Feb 2023. "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.