Class II — C.R. Bard, Inc.
| Recalling firm | C. R. Bard, Inc. |
|---|---|
| Registered facility | View this company's 19 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. |
| Product | 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 the dilation of the nephrostomy tact and for placement of the working sheath. |
| Quantity | 192 units |
| Distribution | Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom. |
| Initiated | 2016-10-12 |
| Classified | 2016-11-04 |
| Terminated | 2021-09-22 |
| Recall number | Z-0363-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C.R. Bard, Inc. (Z-0363-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75452/
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