Device product
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Z-1672-2013
Product summary
- Event
- Event 65317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27
- Official record key
device-enforcement:Z-1672-2013
Official wording
Reason: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Code information: Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798
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.