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Terminated

Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250

FDA Recall Z-0711-03 · Posted 2003-04-09

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeMAF
Date Initiated2003-03-20
Date Terminated2004-07-02
Product Quantity31 stents

Reason for Recall

The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.

Firm Action

Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them.

Root Cause

Other

Distribution Pattern

The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.

Official Source

View FDA Recall →

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

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