Reported Nov 12, 2014 · Terminated
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
St Jude Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St Jude Medical · 1 Saint Jude Medical Dr · Saint Paul, MN · 55117-1789
Is this the product you have?
- St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
- Lot codes and dates
- Batch # 4671318
- Amount recalled
- 26
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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