FDA Recall Terminated

NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.

Recall: Z-1673-2013 · Initiated May 28, 2013

Recall

Recall Number: Z-1673-2013
Event Number: 65317
Firm: Boston Scientific Corporation
FEI Number: 3005099803
Product Code: LJE
Status: Terminated
Root Cause: Process control
Initiated: May 28, 2013
Posted: July 9, 2013
Terminated: January 23, 2014
Address: 100 Boston Scientific Way, Marlborough, MA, 01752-1234

Description

Reason

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

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 Center, 500 Commander Shea Blvd., Quincy, Massachusetts 02171 include original Verification Tracking Form and RGA #. The letter also requests the completion and return of the Account Reply Verification Tracking Form via email to: [email protected] or Fax to: Field Action Center 1-866-213-1806. Follow up communications will be made to the customers that do not respond to this inquiry. Distributors are instructed to forward the recall notification to their customers. If you have any questions call 763-494-1133 or email to [email protected].

Distribution

Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.

Quantity

15 units