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Reprocessed Diagnostic Electrophysiology (EP) Catheters and… recallZ-0340-2014 · Stryker Sustainability Solutions · initiated Oct 18, 2013

Class II Terminated All recalls posted in November 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0340-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 18, 2013
Posted by the FDA
Nov 18, 2013
Recalling firm
Stryker Sustainability Solutions
Quantity
46 units total
Product code
NLH
FDA submissions
K012708, K030109, K030187
Distribution
US Distribution: in the states of: Arizona, California, and Ohio.

Product description

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 (models, lots, serial numbers)

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

Other devices under the same FDA submission

27 devices cleared under K012708, K030109, K030187 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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