FDA Device recall 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 du…
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a du… by C R Bard, citing contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0363-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-12 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | CA, KS, MO, NY, VA, WA |
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.
Reason
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Identifiers
| code_info | Lot BMZCE039, Expiration Date 2018-12-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2017%22
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