Recall Z-1839-2011 ยท DQK Computer, Diagnostic, Programmable
Biosense Webster, Inc.
10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole catheter to an EP recording system.
| Date | Mar 28, 2011 (initiated Feb 15, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue", catalog number D128709, through the J&J Gateway (ie, e-IFU website). |
| Root cause | Other |
| Action | Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated March 16, 2011, to all affected customers (via express mail). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed Acknowledgement Form to confirm that all customers who received the product have been notified accordingly of this concern. If customers have any questions or require additional information, they are to contact their BWI representative and return the Acknowledgement form to: Biosense Webster, Inc. l5715 A |
| Quantity | 606 units total |
| Distribution | Nationwide Distribution - including GA, KY, NV, WA, PA, and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES Biosense Webster, Inc., Oct 13, 2009 |