Z-0116-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 21, 2015
- Initiation Date
- August 19, 2015
- Termination Date
- October 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Reason for Recall
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Distribution Pattern
US Distribution to one location in KY.
Code Information
Lot no. 37603 Expiration date: September 2016