Enforcement Report - Week of January 9, 2013
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0617-2013 |
| Classification | Class III |
| Code Info | Model no. 406586 Batch no. 3619533 |
| Product Distributed Qty | 26 |
| 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. |
Event Detail
| Event Id | 63855 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | St Jude Medical Inc |
| City | Saint Paul |
| State | MN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-28 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Distribution only including the states of FL, KY and OK. |
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