Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
This recall has been terminated (originally issued December 28, 2012).
- Company
- St Jude Medical Inc
- Recall Initiated
- March 28, 2012
- Posted
- December 28, 2012
- Terminated
- July 12, 2013
- Recall Number
- Z-0617-2013
- Quantity
- 26
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Distribution
US Distribution only including the states of FL, KY and OK.
Lot / Code Info
Model no. 406586 Batch no. 3619533
Root Cause
Process control
Action Taken
St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer. The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction. Customers were requested to to complete and return the reconciliation form. Further questions please call (651) 756-6526