Home / Recalls / Arrow International, Inc., Division of Teleflex Medical Inc. / Z-1060-2016

Z-1060-2016 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 40cc; Product Code: IAB-06840-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:18F13M0017 18F13M0019 18F13M0021 18F14A0012 18F14A0013 18F14A0015 18F14A0016 18F14A0044 18F14A0047 18F14B0042 18F14B0043 18F14D0068 18F14E0005 18F14E0007 18F14E0031 18F14E0053 18F14E0069 18F14F0030 18F14F0031 18F14F0066 18F14G0020 18F14G0039 18F14G0066 18F14H0003 18F14H0010 18F14H0023 18F14H0024 18F14H0056 18F14J0006 18F14J0016 18F14J0027 18F14J0051 18F15A0008 18F15A0015 18F15A0023 18F15B0003 18F15B0007 18F15B0021 18F15C0006 18F15C0011 18F15C0027 18F15D0010 18F15D0019 18F15D0045 18F15E0002 18F15E0012 18F15F0008 18F15F0028 18F15F0038 18F15F0041 18F15G0016 18F15G0027 18F15H0005 18F15H0020 18F15H0032 18F15H0041 18F15J0007 18F15J0010 18F15J0021 18F15J0029 18F15J0039 18F15J0056 18F15K0016 18F15K0032 18F15L0001 18F15L0010

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-1059-2016 Class I — UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utiliz (February 10, 2016)