Health product recall

Reprocessed LASSO 2515 NAV eco Variable Catheter (2018-01-02)

Starting date:
January 2, 2018
Posting date:
January 29, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-65786

Affected products

Reprocessed LASSO 2515 NAV eco Variable Catheter

Reason

Stryker sustainability solutions has received an increase in reports indicating that an EEPROM chip error code may occur when reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO EP Navigation Systems. There have been no injuries reported as a result of this event.

Affected products

Reprocessed LASSO 2515 NAV eco Variable Catheter

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

D134301

Companies
Manufacturer
Stryker Sustainability Solutions, Inc.
1810 West Drake Dr.
Tempe
85283
Arizona
UNITED STATES