St. Jude Medical recall
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Why was St. Jude Medical 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # 4671318
- Product
- St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
- Recalling firm
- St Jude Medical
- Quantity
- 26
- Distribution
- US Distribution including the states of CA, GA, NJ, NY, OR and PA.
- Recall date
- November 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)