Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
- Company
- Guidant Cardiac Surgery
- Recall Initiated
- November 19, 2003
- Posted
- July 20, 2004
- Terminated
- March 9, 2004
- Recall Number
- Z-0292-04
- Quantity
- 2597 units
- Firm Location
- Santa Clara, CA
Reason for Recall
VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
Distribution
There are a total of 130 consignees that received the recalled product distributed by Guidant. The firm has identified 0 (zero) wholesaler dealers, 7 distributors or affiliate companies, 0 (zero) retailers and 123 hospitals that received the recalled product distributed by Guidant. The recalled product was distributed in the United States and internationally. Recalled product was distributed by the firm to one (1) government account: USAF Medical Center Keesler, 1301 I Street, Keesler Air Force Base, MS 39534, (228) 377-2778. International countries include: Puerto Rico, Belgium, Chile, France, Germany, Italy and Kuwait.
Lot / Code Info
Lot-- Exp Date: 3081371-- 7/2004, 3081471-- 7/2004, 3081571-- 7/2004, 3081871-- 7/2004, 3081972-- 7/2004, 3082071-- 7/2004, 3082171-- 7/2004, 3082271-- 7/2004, 3082272-- 7/2004, 3082571-- 7/2004, 3082671-- 7/2004, 3082772-- 7/2004, 3082871-- 7/2004, 3082972-- 7/2004, 3090271-- 8/2004, 3090371-- 8/2004, 3090471-- 8/2004, 3090571-- 8/2004, 3090871-- 8/2004, 3090971-- 8/2004, 3091072-- 8/2004, 3091171-- 8/2004, 3091271-- 8/2004, 3091571-- 8/2004, 3091671-- 8/2004, 3091771-- 8/2004, 3091871-- 8/2004, 3091971-- 8/2004, 3092271-- 8/2004, 3092372-- 8/2004, 3092471-- 8/2004, 3092571-- 8/2004, 3092671-- 8/2004, 3100271-- 9/2004
Root Cause
Nonconforming Material/Component
Action Taken
On 11/19/03, the firm issued letters via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.