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 BRACCO ACIST

  • 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 BRACCO ACISTsee related information
Date Initiated by FirmMay 19, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall NumberZ-1002-04
Recall Event ID 29159
510(K)NumberK984231 K991103 
Product Classification Injector And Syringe, Angiographic - Product Code DXT
ProductAngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
Code Information Lot # 0584B 
Recalling Firm/
Manufacturer		 Acist Medical Systems
7450 Flying Cloud Dr Ste 150
Eden Prairie MN 55344-3720
Manufacturer Reason
for Recall		Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
FDA Determined
Cause 2		Other
ActionEach consignee was contacted by telephone and asked to return unused kits with the affected lot number.
Quantity in Commerce3590 kits
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 = DXT
510(K)s with Product Code = DXT
-
-