Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IA

FDA device recall Z-1064-2013 · posted 2013-04-06 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

Action taken

Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.

Root cause

Process control

Status

Terminated

Product code

DSP

Quantity affected

188 units

Distribution

Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.

Date initiated

2012-11-27

Date posted

2013-04-06

Date terminated

2015-06-02

Location

Reading, PA

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