Recall Z-0469-06 ยท DXE Catheter, Embolectomy
Possis Medical, Inc
AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.
| Date | Feb 4, 2006 (initiated Dec 12, 2005) |
| Status | Terminated |
| Reason | It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model. |
| Root cause | Other |
| Action | An Advisory Notice was emailed to OUS Distributors 12/12/2005. The Advisory identifies the product, reason for recall and action Distributor should take. Distributors are to notify their customer who received the affected lot and return it to the Distributor. The Distributor is to open the outer box and inspect the catheter inside the sterile tray. Mislabeled units are to be returned to Possis. |
| Quantity | 48 |
| Distribution | Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042874 | ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) Possis Medical, Inc., Nov 5, 2004 |