Device product
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
Z-1143-2015
Product summary
- Firm
- Angiodynamics
- Event
- Event 70388
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43
- Official record key
device-enforcement:Z-1143-2015
Official wording
Reason: Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.
Code information: Lot No. 4773676, 4776428 and 4780110
Distribution pattern: Worldwide Distribution - US Distribution to the states of AZ, AR, FL, MI, MN, MO, NY, TX, VA, WA and WI., and to the countries of Hungary and Spain.
Derived failure modes
-
Unknown
Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.