Ultra 8 IAB: 8Fr 40cc recall
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…
Why was Ultra 8 IAB: 8Fr 40cc recalled?
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch: 18F14B0044 18F14B0045 18F14E0060 18F14F0019 18F14G0067 18F14H0002 18F14J0026 18F15A0033 18F15B0009 18F15B0019 18F15C0012 18F15D0016 18F15D0037 18F15D0044 18F15F0001
- Product
- 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…
- Recalling firm
- Arrow International, Inc., Division of Teleflex Medical Inc.
- Quantity
- 13,405 US and 33,735 OUS in total
- Distribution
- 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).
- Recall date
- March 16, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)