Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901
FDA device recall Z-0617-2013 · posted 2012-12-28 · Terminated
Recall details
- Recalling firm
- St Jude Medical Inc
- 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.
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 26
- Distribution
- US Distribution only including the states of FL, KY and OK.
- Date initiated
- 2012-03-28
- Date posted
- 2012-12-28
- Date terminated
- 2013-07-12
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (K964518) | Daig Corp. | 1997-05-14 |