EkoSonic Endovascular System recall
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is…
Why was EkoSonic Endovascular System recalled?
The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 150910004. Expiration date is August 15, 2018. Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
- Product
- EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is…
- Recalling firm
- EKOS Corporation
- Quantity
- 10 units
- Distribution
- Distributed in the states of AZ, CA, MA, MI, OH, and VA.
- Recall date
- March 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)