Home / Recalls / Arrow International, Inc., Division of Teleflex Medical Inc. / Z-1059-2016

Z-1059-2016 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

UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-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: 18F13M0016 18F14A0017 18F14A0018 18F14A0022 18F14A0046 18F14E0054 18F14E0070 18F14G0038 18F14G0078 18F14H0007 18F14J0007 18F14J0025 18F14K0016 18F15A0035 18F15B0006 18F15B0014 18F15C0019 18F15E0028 18F15F0016 18F15G0007 18F15H0009 18F15H0035

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-1058-2016 Class I — Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized f (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)