—#47262

Product

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

FDA product code: NVM — Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: MF5124329

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

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

Timeline

Recall initiated: 2006-06-20
Posted by FDA: 2006-10-12
Terminated: 2006-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47262. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.