Z-0565-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2016
- Initiation Date
- November 25, 2015
- Termination Date
- February 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
Reason for Recall
Incorrect version of Instructions for Use were shipped to two US customers.
Distribution Pattern
US Distribution to the states of : CA and FL.
Code Information
Model number: MMRC120-DB-1111; Lot number: B2456974A; Expiry 2016-07. Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.