Percutaneous Insertion Tray recall
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta…
Why was Percutaneous Insertion Tray 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: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028
- Product
- Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta…
- 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)