Food, drugs, devices › C.R. Bard, Inc.
Device recall: X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081
C.R. Bard, Inc. (Covington, GA) initiated this device recall on 12 Oct 2016; FDA lists 1 product record under event 75452, 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 22 Sep 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
"Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr."
Distribution
"Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0363-2017 | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in… | 192 units | Class II | Terminated | 16 Nov 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: "Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr."
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 distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Sep 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.