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
This recall has been terminated (originally issued February 24, 2015).
- Recall Initiated
- December 19, 2014
- Posted
- February 24, 2015
- Terminated
- November 27, 2015
- Recall Number
- Z-1143-2015
- Quantity
- 43
- Firm Location
- Technical Park Glens Falls, NY
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Lot No. 4773676, 4776428 and 4780110
Root Cause
Other
Action Taken
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 affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00a.m. and 7:00p.m. (Monday- Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) following the directions on this page and the Reply Verification Form.