X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation… — Class II medical device recall Z-0363-2017
Terminated recall by C.R. Bard, Inc., reported 2016-11-16, distributed in CA, KS, MO, NY, VA, WA. Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
| Recall number | Z-0363-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2016-10-12 |
| Classified | 2016-11-04 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2021-09-22 |
| Distributed | CA, KS, MO, NY, VA, WA |
| Countries outside the US | CN, GB, IT, SE |
| Quantity | 192 units |
| Lot numbers | BMZCE039 |
| Expiration dates | 2018-12-31 |
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 for recall
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0363-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.