Device product
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.
Z-0116-2016
Product summary
- Event
- Event 72247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0116-2016
Official wording
Reason: One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Code information: Lot no. 37603 Expiration date: September 2016
Distribution pattern: US Distribution to one location in KY.
Derived failure modes
-
Unknown
One Distal Access Catheter intended for distribution in Korea, was found at a US location.