|
Class 3 Device Recall 10 ft. Interface Cable, 10 Pin Shielded Tip Pins to 12 Pin Blue |
|
Date Initiated by Firm |
February 15, 2011 |
Date Posted |
March 28, 2011 |
Recall Status1 |
Terminated 3 on May 07, 2012 |
Recall Number |
Z-1839-2011 |
Recall Event ID |
58104 |
510(K)Number |
K090017
|
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
Product |
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. |
Code Information |
Catalog Number D128709 |
Recalling Firm/ Manufacturer |
Biosense Webster, Inc. 15715 Arrow Hwy Irwindale CA 91706-2006
|
For Additional Information Contact |
909-839-8604
|
Manufacturer Reason for Recall |
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).
|
FDA Determined Cause 2 |
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 Arrow Highway
Irwindale, CA 91706
Attn: Recall Coordinator - Virgil Ellsworth
Phone: (909) 839-8500
Fax Number: (909) 839-7207.
For questions regarding this recall call 909-839-7207. |
Quantity in Commerce |
606 units total |
Distribution |
Nationwide Distribution - including GA, KY, NV, WA, PA, and UT |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DQK and Original Applicant = BIOSENSE WEBSTER, INC.
|
|
|
|