• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Fluid Administration Set

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


New Search Back to Search Results
 Class 2 Recall
Fluid Administration Set
see related information
Date Posted September 11, 2008
Recall Status1 Terminated on April 06, 2009
Recall Number Z-1800-2008
Recall Event ID 47880
Premarket Notification
510(K) Number
K915678 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
Code Information Lot Number F605813
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan, Utah 84095-2416
Manufacturer Reason
for Recall
Convenience kits may contain non-filtered drip chambers.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter.
Quantity in Commerce 99 kits
Distribution Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
-
-