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Terminated

Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051

FDA Recall Z-0031-04 · Posted 2003-10-15

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeLOX
Date Initiated2003-08-20
Date Terminated2005-10-24
Product Quantity6 catheters

Reason for Recall

Some of the recalled catheters have a component that has levels of pyrogens above specification.

Firm Action

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

Root Cause

Other

Distribution Pattern

The recalled products were distributed to consignees located nationwide in the United States.

Official Source

View FDA Recall →

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

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