Class 2 Device Recall Eletrophysiology Catheter; BARD,Daig,BW CristaCath,Response,Supreme,Qwik Cable,BW Webster, Carto 3

• Date Initiated by Firm: October 18, 2013
• Date Posted: November 18, 2013
• Recall Status: Terminated on December 06, 2013
• Recall Number: Z-0340-2014
• Recall Event ID: 66712
• 510(K)Number: K012708 K030109 K030187
• Product Classification: Catheter, recording, electrode, reprocessed - Product Code NLH
• Product: Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
• Code Information: Lot/Serial numbers: 1529652 1535548 1538579 1538655 1562418 1562420 1568434 1568478 1596050 1258475 1596051 1535068 1535071 1535072 1559331 1363123 1406041 1531413 1533378 1533385 1535540 1596047 1596048 1471197 1539560 1539561 1541119 1596049 757895 1600879 1520424 1558826 1558827 1600880 1600881 1558103 1434511 1464987 1600882 1313231 1600883 1600884 1401578 1570964 1600670 1600671
• FEI Number: 3009350690
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: 269-385-2600
• Manufacturer Reason for Recall: Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
• FDA Determined Cause: Process control
• Action: Stryker sent an Urgent Medical Device Removal Notification letter to affected customers. The letter informed customers of the affected product, problem identified and the actions to be taken. Customers are instructed to complete the "Recall Effectiveness Form" and fax to Moira Barton-Varty, Senior Director Regulatory Affairs at (480) 809-4957. Customers with any serious adverse events or product problems are instructed to call Stryker Sustainability Solutions at (888) 763-8803.
• Quantity in Commerce: 46 units total
• Distribution: US Distribution: in the states of: Arizona, California, and Ohio.
• 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 = NLH; 510(K)s with Product Code = NLH