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 3 Device Recall Thermodilution 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 3 Device Recall Thermodilution cathetersee related information
Date Initiated by FirmNovember 19, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 14, 2004
Recall NumberZ-0305-04
Recall Event ID 27788
510(K)NumberK812800 K832957 
Product Classification Catheter, Flow Directed - Product Code DYG
ProductPentalumen TD Thermodilution Catheter, Sterile
Code Information List No. 41233-01, Lot 04-187-SN
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact
847-937-4524
Manufacturer Reason
for Recall		Thermodilution catheters have a potential for ruptured lumens within the catheter.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on 11/19/2003.
Quantity in Commerce495 units
DistributionAR,AZ, CA, FL, LA, MA, NC, OR, PA, TN, TX, UT, VA, WA. VA facilities in AR,AZ,FL and NC. No military or foreign 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 = DYG
-
-