Recall Z-1672-2013 ยท LJE Catheter, Nephrostomy
Boston Scientific Corporation
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
| Date | Jul 9, 2013 (initiated May 28, 2013) |
| Status | Terminated |
| Reason | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. |
| Root cause | Process control |
| Action | The firm, Boston Scientific, sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated May 28, 2013, consignees via Federal Express Priority Mail to its consignees/customers.OUS - Customer notification letters has also been sent to consignees/customers in the EU. The letter instructs the customers to Immediately discontinue use of and segregate recalled product; check their inventory; immediately remove all affected product from their inventory, and return it to Boston Scientific at Boston Scientific Corporation, US Distribution Center, Customer Fulfillment Cen |
| Quantity | 27 |
| Distribution | Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121614 | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER Boston Scientific Corp, Sep 18, 2012 |