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U.S. Department of Health and Human Services

Class 2 Device Recall Deltec PortACath

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  Class 2 Device Recall Deltec PortACath see related information
Date Initiated by Firm March 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-0864-04
Recall Event ID 28667
510(K)Number K973862  
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Product Port-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 Contact Mike 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
Action A 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.
Distribution The recalled products were shipped nationwide in the United States and worldwide.
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 = LJT and Original Applicant = SIMS DELTEC, INC.
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