Device 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.
Z-0363-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 75452
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 units
- Official record key
device-enforcement:Z-0363-2017
Official wording
Reason: Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Code information: Lot BMZCE039, Expiration Date 2018-12-31
Distribution pattern: Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
Derived failure modes
-
Unknown
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.