UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation

FDA device recall Z-1060-2016 · posted 2016-03-11 · Terminated

Recall details

Recalling firm

Arrow International, Inc., Division of Teleflex Medical Inc.

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.

Action taken

The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Process control

Status

Terminated

Product code

DSP

Quantity affected

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, I

Date initiated

2016-02-10

Date posted

2016-03-11

Date terminated

2021-05-12

Location

Everett, MA

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