10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number

FDA device recall Z-1839-2011 · posted 2011-03-28 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

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).

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DQK

Quantity affected

606 units total

Distribution

Nationwide Distribution - including GA, KY, NV, WA, PA, and UT

Date initiated

2011-02-15

Date posted

2011-03-28

Date terminated

2012-05-07

Location

Irwindale, CA

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