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 Straight Cardiac Pigtail Catheter

  • 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 Straight Cardiac Pigtail Cathetersee related information
Date Initiated by FirmNovember 05, 2003
Date PostedNovember 27, 2003
Recall Status1 Terminated 3 on December 01, 2003
Recall NumberZ-0158-04
Recall Event ID 27749
510(K)NumberK943739 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
ProductUHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
Code Information Catalog Number7779-10, Lots G270628, G283744, G260778.
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		Angiographic catheter tips may separate during use.
FDA Determined
Cause 2		Other
ActionAll 7 consignees were contacted by their sales representatives on 11/5-7/2003.
Quantity in Commerce410 units
DistributionFL, MI, NY, PA, TN, TX. No foreign, government, or military distribution.
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 = DQO
-
-