VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations:
FDA device recall Z-0476-2009 · posted 2008-12-23 · Terminated
Recall details
- Recalling firm
- CTS, Inc. dba Guidant Cardiac Surgery
- Reason for recall
- Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874.
- Action taken
- The firm issued a letter entitled "URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 7,935 units
- Distribution
- Worldwide Distribution --- including USA and country of Australia.
- Date initiated
- 2008-09-09
- Date posted
- 2008-12-23
- Date terminated
- 2010-12-08
- Location
- San Jose, CA
Monitor recalls programmatically
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