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Terminated

Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

FDA Recall Z-0010-04 · Posted 2003-10-15

Recalling FirmBard Peripheral Vascular
Recall StatusTerminated
Product CodeDQY
Date Initiated2003-09-18
Date Terminated2004-12-10
Product Quantity124

Reason for Recall

Mislabeled. 7mm balloon labeled 12mm

Firm Action

Recall was by letter dated 9/17/2003. Return of the devices is requested under a return authorization number. A fax back form was included to confirm receipt and compliance.

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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