Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Thermal dot matrix printer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Thermal dot matrix printersee related information
Date Initiated by FirmNovember 07, 2005
Date PostedJanuary 06, 2006
Recall Status1 Terminated 3 on March 14, 2006
Recall NumberZ-0349-06
Recall Event ID 34082
510(K)NumberK993341 
Product Classification Syringe, Balloon Inflation - Product Code MAV
ProductIntelliSystem 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
ActionSale representatives and consignees were notified by letter.
Quantity in Commerce35 units
DistributionDevice 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 CycleTPLC 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) Database510(K)s with Product Code = MAV
-
-