FDA-Device2014-11-12Class II
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
St Jude Medical
Hazard
St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
Sold states
US Distribution including the states of CA, GA, NJ, NY, OR and PA.
Affected count
26
Manufactured in
1 Saint Jude Medical Dr, N/A, Saint Paul, MN, United States
Products
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0177-2015Don'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