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Terminated

Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.

FDA Recall Z-0030-2007 · Posted 2006-10-12

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeNVM
Date Initiated2006-06-20
Date Terminated2006-10-16
Product Quantity11 units

Reason for Recall

The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.

Firm Action

Recall letter was sent to customers on 6/20/2006 by US mail.

Root Cause

Other

Distribution Pattern

Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.

Official Source

View FDA Recall →

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

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