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

Class 2 Device Recall Medrad Avanta Multipatient Disposable Sets

  • 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 Medrad Avanta Multipatient Disposable Sets see related information
Date Initiated by Firm September 20, 2005
Date Posted October 21, 2005
Recall Status1 Terminated 3 on January 20, 2006
Recall Number Z-0083-06
Recall Event ID 33689
510(K)Number K050456  
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
Code Information Lot numbers 50627, 50628, 51069, 51070, 51071, and 51747
Recalling Firm/
Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Laurence R. Kopyta
412-767-2400 Ext. 3621
Manufacturer Reason
for Recall
stress crack on the stopcock
FDA Determined
Cause 2
Action The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
Quantity in Commerce 850 units
Distribution The products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and Italy.
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 = LHI and Original Applicant = MEDRAD, INC.