EKOS Corporation

CIC Serial Numbers:  19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103,  19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112,  19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118,  19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127,  19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135,  19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144,  19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153,  19598-154, 19598-156, 19598-157, 19598-158.

Cardiovascular Devices

2

No

Nationwide Distribution

The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. || The EkoSonic Endovascular System consists of three main components: || -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and || -removable MicroSonic Device (MSD), and || -a reusable EKOS EkoSonic Control System. || During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. || The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. || A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

Lot Number 150910004. Expiration date is August 15, 2018.  Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010

Cardiovascular Devices

2

No

Distributed in the states of AZ, CA, MA, MI, OH, and VA.

EkoSonic Endovascular System, Catalog Number 500-56112. || It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. || During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. || The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface || Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

Lot numbers: 030915 032615 040915 061515 071515 081715 103015 120715 010416 011816 022216 032116 052416

General Hospital and Personal Use Devices

1

No

US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY.

The EKOS cart has the catalog number 700-60101. || The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.

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.

Cardiovascular Devices

2

No

Three international consignees - Germany, New Zealand and Taiwan

EkoSonic Endovascular Devices || EKOS Intelligent Drug Delivery Catheter

CIC Connector Clip Part Number: 700-4000; Lot numbers: 080324024, 080324025, 080324026, 080324027, 080325002, 080325003. EndoWave System Control Unit S/N: PT3B-001, PT3B-002, PT3B-004, PT3B-006, PT3B-007, PT3B-008, PT3B-009, PT3B-010, PT3B-011, PT3B-012, PT3B-013, PT3B-014, PT3B-017, PT3B-018, PT3B-020, PT3B-021, PT3B-022, PT3B-024, PT3B-025, PT3B-027, PT3B-029, PT3B-030, PT3B-031, PT3B-032, PT3B-033, PT3B-034, PT3B-035, PT3B-037, PT3B-038, PT3B-040, PT3B-041, PT3B-042, PT3B-043, PT3B-044, PT3B-045, PT3B-046, PT3B-047, PT3B-049, PT3B-050, PT3B-051, PT3B-052, PT3B-057, PT3B-058, PT3B-059, PT3B-060, PT3B-062, PT3B-063, PT3B-064, PT3B-065, PT3B-066, PT3B-067, PT3B-068, PT3B-070, PT3B-071, PT3B-072, PT3B-073, PT3B-074, PT3B-075, PT3B-076, PT3B-078, PT3B-079, PT3B-080, PT3B-082, PT3B-084, PT3B-085, PT3B-087, PT3B-088, PT3B-089, PT3B-090, PT3B-091, PT3B-093, PT3B-094, PT3B-095, PT3B-096, PT3B-097, PT3B-098, PT3B-099, PT3B-100, PT3B-102, PT3B-103, PT3B-104, PT3B-108, PT3B-109, PT3B-110, PT3B-111, PT3B-112, PT3B-113, PT3B-114, PT3B-115, PT3B-118, PT3B-119, PT3B-121, PT3B-123, PT3B-124, PT3B-127, PT3B-128, PT3B-130, PT3B-131, PT3B-132, PT3B-133, PT3B-135, PT3B-137, PT3B-138, PT3B-139, PT3B-140, PT3B-141, PT3B-143, PT3B-145, PT3B-146, PT3B-147, PT3B-148, PT3B-150, PT3B-151, PT3B-152, PT3B-153, PT3B-154, PT3B-155, PT3B-156, PT3B-157, PT3B-158, PT3B-159, PT3B-163, PT3B-164, PT3B-165, PT3B-168, PT3B-169, PT3B-172, PT3B-173, PT3B-174, PT3B-175, PT3B-176, PT3B-177, PT3B-178, PT3B-180, PT3B-181, PT3B-183, PT3B-186, PT3B-188, PT3B-192, PT3B-193, PT3B-195, PT3B-196, PT3B-197, PT3B-199, PT3B-201, PT3B-202, PT3B-204, PT3B-205, PT3B-206, PT3B-207, PT3B-208, PT3B-210, PT3B-211, PT3B-212, PT3B-214, PT3B-215, PT3B-217, PT3B-218, PT3B-219, PT3B-221, PT3B-253, PT3B-254, PT3B-255, PT3B-256, PT3B-257, PT3B-258, PT3B-259, PT3B-260, PT3B-261, PT3B-262, PT3B-263, PT3B-264, PT3B-265, PT3B-266, PT3B-267, PT3B-268, PT3B-269, PT3B-270, PT3B-271, PT3B-273, PT3B-274, PT3B-275, PT3B-276, PT3B-280, PT3B-285, PT3B-286, PT3B-287, PT3B-288, PT3B-289, PT3B-291, PT3B-292, PT3B-294, PT3B-295, PT3B-297, PT3B-298, PT3B-308, PT3B-310, PT3B-311, PT3B-312, PT3B-313, PT3B-314, PT3B-315, PT3B-316, PT3B-319, PT3B-320, PT3B-321, PT3B-323, PT3B-326, PT3B-328, PT3B-329, PT3B-332, PT3B-333, PT3B-334, PT3B-335, PT3B-337, PT3B-338, PT3B-339, and PT3B-344.

Cardiovascular Devices

2

No

Class II Recall - Nationwide

Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature.