EkoSonic Endovascular Devices EKOS Intelligent Drug recall
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Why was EkoSonic Endovascular Devices EKOS Intelligent Drug recalled?
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
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?
Table 1: Device Identification Information Catalog Number; Lot Number; Serial Number; Expiration Date 500-5518; 160711017; 160711017-005; 06-30-2019 500-5518; 160711017; 160711017-006; 06-30-2019. 500-5518; 160711017; 160711017-003; 06-30-2019. 500-5518; 160711017; 160711017-004; 06-30-2019. 500-5512; 160711042; 160711042-010; 06-30-2019. 500-5518; 160711017; 160711017-001; 06-30-2019. 500-5518; 160711017; 160711017-002; 06-30-2019. 500-5518; 160711017; 160711017-007; 06-30-2019. 500-5518; 160711017; 160711017-008; 06-30-2019. 500-5518; 160711017; 160711017-009; 06-30-2019. 3001627457 08/09/2016-002R CONFIDENTIAL 3 ¿ Name, address, and type of responsible firm on label; number and description of private labels. Manufacturer: EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011 ¿ Collect a complete copy of all labeling (include product inserts, information sheets.) Applicable labeling is included in Attachment 1. B. CODE: ALL lot and/or serial numbers, batch numbers, catalog numbers, product numbers, packer or manufacturer numbers, etc., exactly as they appear on the product, container, or labeling. There are 10 total devices in distribution. Identification information for the implicated devices is found in Table 1: Table 1: Device Identification Information Catalog Number Lot Number Serial Number Expiration Date 500-5518 160711017 160711017-005 06-30-2019 500-5518 160711017 160711017-006 06-30-2019 500-5518 160711017 160711017-003 06-30-2019 500-5518 160711017 160711017-004 06-30-2019 500-5512 160711042 160711042-010 06-30-2019 500-5518 160711017 160711017-001 06-30-2019 500-5518 160711017 160711017-002 06-30-2019 500-5518 160711017 160711017-007 06-30-2019 500-5518 160711017 160711017-008 06-30-2019 500-5518 160711017 160711017-009 06-30-2019 ¿ Give a breakdown of the code Catalog Number consists of 7 digits (XXX-YYYY), where; ¿ XXX represents a product family, ¿ YYYY represents a specific configuration, such as working length/treatment zone length.
- Product
- EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
- Recalling firm
- EKOS Corporation
- Quantity
- 10 units
- Distribution
- Three international consignees - Germany, New Zealand and Taiwan
- Recall date
- September 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)