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

Class 2 Device Recall Deltec PortACath

  • 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 Deltec PortACathsee related information
Date Initiated by FirmMarch 29, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on December 28, 2006
Recall NumberZ-0864-04
Recall Event ID 28667
510(K)NumberK973862 
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
ProductPort-A-Cath Low Profile Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4037-24
Code Information Lots M27118 and M27262
Recalling Firm/
Manufacturer
Deltec, Inc
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information ContactMike Herbert
651-628-7049
Manufacturer Reason
for Recall
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
FDA Determined
Cause 2
Other
ActionA recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
DistributionThe recalled products were shipped nationwide in the United States and worldwide.
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 = LJT
-
-