CATH. GUIDE 8F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or
FDA device recall Z-0995-06 · posted 2006-06-01 · Terminated
Recall details
- Recalling firm
- Medtronic, Inc.
- Reason for recall
- Potential for non-sterility due to loss of package integrity
- Action taken
- Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 9 units
- Distribution
- Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, S
- Date initiated
- 2006-04-05
- Date posted
- 2006-06-01
- Date terminated
- 2007-06-20
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 8F LAUNCHER GUIDE CATHETER (K023402) | Medtronic Vascular | 2002-11-06 |