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U.S. Department of Health and Human Services

Class 3 Device Recall 10 ft. Interface Cable, 10 Pin Shielded Tip Pins to 12 Pin Blue

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 Class 3 Recall
10 ft. Interface Cable, 10 Pin Shielded Tip Pins to 12 Pin Blue
see related information
Date Posted March 28, 2011
Recall Status1 Terminated on May 07, 2012
Recall Number Z-1839-2011
Recall Event ID 58104
Premarket Notification
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, California 91706-2006
Consumer Instructions Contact the recalling firm for information
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/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = BIOSENSE WEBSTER, INC.
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