Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arv
FDA device recall Z-0625-2010 · posted 2010-01-14 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Vessel clamping device may break during use.
- Action taken
- Consignees were notified by "Urgent Field Safety Notice" dated November 24, 2009 with instructions to examine the device before, during and after use. Customers were instructed to not use the device, if it is damaged. Customers were also instructed to contact the Sorin Group Customer Service at 1-800-650-2623 to arrange shipment of replacement product and requested to complete and return the response form. Direct questions to the Sorin Group Customer Service at 1-800-650-2623.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 534 units
- Distribution
- Worldwide Distribution -- United States, Australia, Canada and Italy.
- Date initiated
- 2009-11-25
- Date posted
- 2010-01-14
- Date terminated
- 2010-10-04
- 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 |
|---|---|---|
| CLEARGLIDE PRECISION BIPOLAR DEVICE (K003587) | ETHICON, Inc. | 2000-12-04 |