Recall Z-0380-2017
Stryker Sustainability Solutions · initiated October 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 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.
Codes / lots: 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
Reason for recall
The EP Catheters may be mislabeled for French size during reprocessing.
FDA-determined cause: Under Investigation by firm
Action taken
The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/6/2016 to its customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. To complete and Return the Recall Effectiveness Check Form, even if no affected product is found, to your local Stryker Sustainability Sales Representative or email to SSSPFA@stryker.com or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If you have any questions, contact Senior Director RA at 1(888)888-3433.
Details
- Recall number
- Z-0380-2017
- Initiated
- October 6, 2016
- Terminated
- December 16, 2016
- Product code
- NLH – Catheter, Recording, Electrode, Reprocessed
- Quantity
- 4 devices
- Distribution
- U.S. distribution to the following; AZ, MN and MO.
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ