Food, drugs, devices › C.R. Bard, Inc.
Device recall: Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
FDA enforcement event 80150 is a device recall by C.R. Bard, Inc. of Covington, GA, initiated 13 Dec 2017 and classified Class II, with 1 product record.
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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 14 Dec 2020. 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
"Foley Catheter with Incorrect Retainer Cap Print"
Distribution
"FL, NY, MN and TX Canada, Japan and Taiwan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2064-2018 | Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522) | N/A | Class II | Terminated | 13 Jun 2018 |
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: "Foley Catheter with Incorrect Retainer Cap Print"
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: "FL, NY, MN and TX Canada, Japan and Taiwan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Dec 2020. "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.