EKOS EkoSonic Endovascular System Recalled for Incorrect Working Length Labeling
EKOS Corporation is recalling 10 units of the EkoSonic Endovascular System because the device is labeled with a 135 cm working length, but the actual working length is 106 cm.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error regarding working length. No injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity score involving minor labeling errors or low-risk issues.
Plain-English summary
EKOS Corporation is recalling 10 units of the EkoSonic Endovascular System, Catalog Number 500-56112. The recall involves Lot Number 150910004, with an expiration date of August 15, 2018, and serial numbers 001 through 010. The affected units were distributed in Arizona, California, Massachusetts, Michigan, Ohio, and Virginia.
The recall was initiated because the EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC), is labeled with a 135 cm working length and programmed with a 135 cm family code. However, the actual working length of the MSD is 106 cm. This discrepancy between the labeled specifications and the physical device characteristics constitutes the basis for the recall.
The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should stop using the affected devices and contact EKOS Corporation for further instructions.
The recalled product
- Product
- 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 Contro
- Manufacturer
- EKOS Corporation
- Category
- Medical Device — Endovascular
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot Number 150910004. Expiration date is August 15
- 2018. Serial numbers: 001
- 002
- 003
- 004
- 005
- 006
- 007
- 008
- 009
- 010
Distribution
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