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Terminated

MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

FDA Recall Z-0862-03 · Posted 2003-05-22

Recalling FirmGuidant Corporation ACS
Recall StatusTerminated
Product CodeMAF
Date Initiated2003-05-07
Date Terminated2004-12-01
Product Quantity40

Reason for Recall

Sterility compromised.

Firm Action

The firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.

Root Cause

Other

Distribution Pattern

NATIONWIDE

Official Source

View FDA Recall →

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

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