Recall Z-1143-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Angiodynamics
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
| Date | Feb 24, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | AngioDynamics sent an Urgent Medical Device Recall - Immediate Action Required letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. If a |
| Quantity | 43 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992693 | RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 Rita Medical Systems, Sep 10, 1999 |