Recalls / —

—#43087

Product

IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.

FDA product code

MAV — Syringe, Balloon Inflation

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K993341

Affected lot / code info

Catalog Number IN1615. Serial Numbers: T2370-0025, T2370-0035, T2370-0037, T2370-0046, T2370-0053, T2370-0057, T2370-0058, T2370-0068, T2370-0069, T2370-0071, T2370-0072, T2370-0073, T2370-0075, T2370-0076, T2370-0077, T2370-0078, T2482-0013, T2482--0020, T2482-0030, T2482-0032, T2482-0035, T2482-0041, T2482-0043, T2482-0065.

Why it was recalled

Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.

Root cause (FDA determination)

Other

Action the firm took

Sale representatives and consignees were notified by letter.

Recalling firm

Firm

Merit Medical Systems, Inc

Address

1600 West Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

Device was distributed in the US, Canada and worlwide. US distribution includes: AL, IN, MD, MS, NJ, OH, OR, PA, TN, TX, and WA. Foreign consignees include: Argentinal, Australia, Belgium, Brazil, France, Germany, Israel, Japan, Mexico, Netherland, New Zealand, UK and Wales.

Timeline

Recall initiated

2005-11-07

Posted by FDA

2006-01-06

Terminated

2006-03-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.