Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufac
FDA device recall Z-0614-2011 · posted 2010-12-13 · Terminated
Recall details
- Recalling firm
- CTS, Inc. dba Guidant Cardiac Surgery
- Reason for recall
- Sterility may be compromised by a loss of package integrity.
- Action taken
- Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form. Maquet can be contacted at 888-880-2874 concerning this recall.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- GCJ
- Distribution
- Distribution: Nationwide and Internationally.
- Date initiated
- 2009-02-05
- Date posted
- 2010-12-13
- Date terminated
- 2011-01-19
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM (K030512) | Guidant Corp. | 2003-05-14 |