Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 ...
FDA Recall #Z-1102-2018 — Class II — December 12, 2017
Product Description
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
Reason for Recall
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2224
Distribution
Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.
Code Information
Expiration Date Range: 3/27/2018 9/25/2021; Batch: 16852983 18912864 20404111 16969146 18932466 20458384 16987703 19157072 20491745 17078511 19318043 20517724 17159358 19338399 20567074 17248134 19596298 20567075 17672818 19623064 20593962 17780452 19705478 20658862 17910342 19737920 20682997 17960225 19850692 20735792 17976830 19934631 20769252 18100917 20065714 20830243 18106456 20169834 20884298 18172896 20198263 20909294 18280357 20284828 21027051 18398908 20312727 21101918 18821698 20330766 21181528 18876334
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated