FDA Enforcement
Class II
Terminated
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.
Recall: Z-0363-2017
·
Reported November 16, 2016
Enforcement
- Recall Number
- Z-0363-2017
- Event ID
- 75452
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- C.R. Bard, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 16, 2016
- Initiation Date
- October 12, 2016
- Classification Date
- November 4, 2016
- Termination Date
- September 22, 2021
- Address
- 8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States
Description
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.
Code Info
Lot BMZCE039, Expiration Date 2018-12-31
Distribution
Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
Quantity
192 units