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Terminated

Viceroy Inflation Syringe, 60mL, without gauge.

FDA Recall Z-0291-06 · Posted 2005-12-17

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeMAV
Date Initiated2005-10-21
Date Terminated2006-05-25
Product Quantity62 units

Reason for Recall

Inflation device may not hold vacuum during angioplasty procedure.

Firm Action

All consignees were notified by fax and letter on 10/21/2005.

Root Cause

Other

Distribution Pattern

FL, UT. Foreign distribution to Austria, Cyprus, Czechoslovakia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Israel, Italy, Japan, Jordan, Kuwait, Netherlands, Norway, Poland, Saudi Arabia, Slovenia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE. No government or military distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040138VICEROY INFLATION DEVICEMerit Medical Systems, Inc. · 2004-02-13

Official Source

View FDA Recall →

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

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