Recall Z-2568-2014 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
| Date | Sep 3, 2014 (initiated Aug 11, 2014) |
| Status | Terminated |
| Reason | During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter. |
| Root cause | Labeling False and Misleading |
| Action | Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST). |
| Quantity | one unit |
| Distribution | US Distribution to TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES Datascope Corp., Jun 7, 2004 |