Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nor
FDA device recall Z-0192-2010 · posted 2009-11-13 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.
- Action taken
- Customers were notified by an Urgent: Field Safety Notice, dated 9/25/09, and instructed to: check their inventory for the affected product, complete the customer response form and return or visually inspect all affected product before use. For additional information contact Sorin Group Customer Service at 1-800-650-2623.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 808 units
- Distribution
- Worldwide Distribution -- US, Canada, Japan, and Europe.
- Date initiated
- 2009-09-25
- Date posted
- 2009-11-13
- Date terminated
- 2009-12-14
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBE REVOLUTION (K011835) | Cobe Cardiovascular, Inc. | 2002-02-12 |