FDAFDA · Food and drugs·Recall number Z-1062-2016
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Published March 16, 2016 · Recall initiated: February 10, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International, Inc., Division of Teleflex Medical Inc.
- Distributor
- Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
- Lot
- Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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