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.
This recall has been terminated (originally issued February 4, 2006).
- Company
- Possis Medical, Inc
- Recall Initiated
- December 12, 2005
- Posted
- February 4, 2006
- Terminated
- November 8, 2006
- Recall Number
- Z-0469-06
- Quantity
- 48
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.
Lot / Code Info
model number: 105421-002, Lot number 56594
Root Cause
Other
Action Taken
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.