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Terminated

VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.

FDA Recall Z-0476-2009 · Posted 2008-12-23

Recalling FirmCTS, Inc. dba Guidant Cardiac Surgery
Recall StatusTerminated
Product CodeGCJ
Date Initiated2008-09-09
Date Terminated2010-12-08
Product Quantity7,935 units

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution --- including USA and country of Australia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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