Home / Recalls / Arrow International, Inc., Division of Teleflex Medical Inc. / Z-1061-2016

Z-1061-2016 Class I Terminated

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

FDA device recall Z-1061-2016 was initiated by Arrow International, Inc., Division of Teleflex Medical Inc. on February 10, 2016 and is designated Class I. 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. The recall status is terminated (terminated May 12, 2021). Affected quantity: 13,405 US and 33,735 OUS in total.

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

RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C 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:18F14A0041 18F14C0003 18F14C0006 18F14C0021 18F14C0026 18F14C0027 18F14C0028 18F14E0039 18F14E0055 18F14E0058 18F14F0035 18F14F0038 18F14F0054 18F14G0057 18F14G0077 18F14H0011 18F15B0023 18F15C0001 18F15C0008 18F15C0026 18F15D0028 18F15F0027 18F15F0037 18F15G0003 18F15G0011 18F15G0032 18F15H0046 18F15M0009

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-1057-2016 Class I — FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB (February 10, 2016)
Z-1062-2016 Class I — Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utiliz (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-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)