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U.S. Department of Health and Human Services

Class 2 Device Recall Thermal dot matrix printer

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  Class 2 Device Recall Thermal dot matrix printer see related information
Date Initiated by Firm November 07, 2005
Date Posted January 06, 2006
Recall Status1 Terminated 3 on March 14, 2006
Recall Number Z-0349-06
Recall Event ID 34082
510(K)Number K993341  
Product Classification Syringe, Balloon Inflation - Product Code MAV
Product IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable
Code Information Catalog Number IN1600/A. Serial Numbers: T2370-0008, T2370-0009, T2370-0011, T2370-0016, T2370-0017, T2482-0037, T2370-0039, T2370-0040, T2370-0042, T2370-0051, T2370-0054, T2370-0056, T2370-0060, T2370-0065, T2482-0002, T2482-0025, T2482-0034, T2482-0046, T2482-0049, T2482-0055, T2482-0058, T2482-0068, T2482-0069, T2482-0071, T2482-0073, T2482-00078, T2482-0081, T2482-0084, T2482-0085, T2482-0089, T2482-0091, T2482-0094, T2483A-0018, T2483A-0019, T2483A-0022.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 West Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-208-4405
Manufacturer Reason
for Recall		 Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
FDA Determined
Cause 2		 Other
Action Sale representatives and consignees were notified by letter.
Quantity in Commerce 35 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAV and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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