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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-0351-06
Recall Event ID 34082
510(K)Number K993341  
Product Classification Syringe, Balloon Inflation - Product Code MAV
Product IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
Code Information 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.
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 38 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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