Recalls / —
—#43088
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/A. Serial Numbers: T2482-0005, T2482-0006, T2482-0009, T2482-0010, T2482-0017, T2482-0018, T2483A-0025, T2483A-0026, T2482-0028, T2482-0033, T2482-0048, T2482-0050, T2482-0056, T2482-0059, T2482-0064, T2482-0070, T2482-0074, T2482-0076, T2482-0080, T2482-0082, T2482-0086, T2482-0087, T2482-0090, T2482-0093, T2483A-0004, T2483A-0015, T2483A-0023, T2483A-0032, T2483A-0037, T2483A-0042, T2483A-0046, T2483A-0074, T2483A-0080, T2483A-0081, T2483-0082, T2483A-0094, T2483A-0095, T2483A-0100.
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 #43088. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.