Recall Z-0177-2015— St Jude Medical
Class II · Terminated
Class II FDA medical device recall by St Jude Medical, initiated 2014-10-14, terminated 2014-12-10. It names one FDA 510(k) clearance: K894500. Product: St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353. Reason: 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.
- Recalling firm
- St Jude Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-14
- Terminated
- 2014-12-10
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.