Device product
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Z-1673-2013
Product summary
- Event
- Event 65317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-1673-2013
Official wording
Reason: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Code information: Lot Number: 15982017, 15963887, 16034014
Distribution pattern: Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
Derived failure modes
-
Unknown
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.