Guidant Multi-Link Zeta Coronary Stent System
FDA Recall Z-1075-03 · Posted 2003-08-01
Recalling FirmGuidant Corporation ACS
Recall StatusTerminated
Date Initiated2003-07-15
Date Terminated2004-04-14
Product QuantityNot stated
Reason for Recall
Potential loss of package sterility.
Firm Action
Firm personnel in China have inspected all Chinese consignee end user inventories. Any units found to be defective have been removed and are currently in Guidant control.
Root Cause
Other
Distribution Pattern
China
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.