AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with E
FDA device recall Z-0469-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Possis Medical, Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 48
- Distribution
- Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.
- Date initiated
- 2005-12-12
- Date posted
- 2006-02-04
- Date terminated
- 2006-11-08
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) (K042874) | Possis Medical, Inc. | 2004-11-05 |