FDA-Device2016-06-01Class II

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Stryker Sustainability Solutions
Hazard

Mislabeled for size

Sold states
Distributed in the state of NY and the country of Canada.
Affected count
18 devices
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1708-2016

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief