Reported Nov 16, 2016 · Terminated

Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940,…

Stryker Sustainability Solutions

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327

Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology
Catheters Model Numbers
- 401940
- 402004
UPC Code00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures

Lot codes and dates: Item Number Serial Number Manufacturing Date
401940
1902898
3/31/2015
401940
1908621
3/31/2015
402004
1902392
1/9/2015
402004
1902389
1/9/2015
Amount recalled: 4 devices

The EP Catheters may be mislabeled for French size during reprocessing.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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