Home / Recalls / Arrow International, Inc., Division of Teleflex Medical Inc. / Z-1058-2016

Z-1058-2016 Class I Terminated

Recalled by Arrow International, Inc., Division of Teleflex Medical Inc. — Everett, MA

Recall Details

Product Type
Devices
Report Date
March 16, 2016
Initiation Date
February 10, 2016
Termination Date
May 12, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,405 US and 33,735 OUS in total

Product Description

Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U 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.

Reason for Recall

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Distribution Pattern

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).

Code Information

Batch: 18F14B0044 18F14B0045 18F14E0060 18F14F0019 18F14G0067 18F14H0002 18F14J0026 18F15A0033 18F15B0009 18F15B0019 18F15C0012 18F15D0016 18F15D0037 18F15D0044 18F15F0001

Other recalls by Arrow International, Inc., Division of Teleflex Medical Inc.

  • Z-1055-2016 Class I — FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic (February 10, 2016)
  • Z-1063-2016 Class I — Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilize (February 10, 2016)
  • Z-1056-2016 Class I — Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized f (February 10, 2016)
  • Z-1057-2016 Class I — FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB (February 10, 2016)
  • Z-1061-2016 Class I — RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized f (February 10, 2016)
  • Z-1062-2016 Class I — Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utiliz (February 10, 2016)
  • Z-1060-2016 Class I — UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utiliz (February 10, 2016)
  • Z-1059-2016 Class I — UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utiliz (February 10, 2016)