Recall Z-0617-2013 ยท DYB Introducer, Catheter
St Jude Medical Inc
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.
| Date | Dec 28, 2012 (initiated Mar 28, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 26 |
| Distribution | US Distribution only including the states of FL, KY and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER Daig Corp., May 14, 1997 |