Recall Z-1233-2015 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow International Inc
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
| Date | Mar 2, 2015 (initiated Feb 5, 2015) |
| Status | Terminated |
| Reason | Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr |
| Root cause | Labeling mix-ups |
| Action | Arrow International notified Users, Distributors, Risk Managers by letter dated February 5, 2015. The letter explains the labeling error and requests immediately discontinue use and quarantine product. Customers were instructed to complete the Recall Acknowledgement Form and return by fax to 1-855-419-8507 whether they have or do not have the affected product. Customers with questions were instructed to contact their local sales representataive or Customers Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131. |
| Quantity | 165 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 Arrow Intl., Inc., Jun 6, 2002 |