FDAFDA · Food and drugs·Recall number Z-0177-2015
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Published November 12, 2014 · Recall initiated: October 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical
- Distributor
- US Distribution including the states of CA, GA, NJ, NY, OR and PA.
- Lot
- Batch # 4671318
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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