Recall Z-1064-2013 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
| Date | Apr 6, 2013 (initiated Nov 27, 2012) |
| Status | Terminated |
| Reason | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 188 units |
| Distribution | Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa. |
| FDA record | Open on fda.gov |