Recall Z-0177-2015
St Jude Medical · initiated October 14, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Codes / lots: Batch # 4671318
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
FDA-determined cause: Labeling mix-ups
Action taken
St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.
Details
- Recall number
- Z-0177-2015
- Initiated
- October 14, 2014
- Posted by FDA
- November 6, 2014
- Terminated
- December 10, 2014
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Quantity
- 26
- Distribution
- US Distribution including the states of CA, GA, NJ, NY, OR and PA.
- Recalling firm
- St Jude Medical, Saint Paul, MN