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Class 2 Device Recall Deltec Ventra |
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Date Initiated by Firm |
July 08, 2003 |
Date Posted |
July 30, 2003 |
Recall Status1 |
Terminated 3 on July 02, 2004 |
Recall Number |
Z-1066-03 |
Recall Event ID |
26715 |
510(K)Number |
K904334
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Product Classification |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
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Product |
Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and Single-Lumen Catheters, Reorder Number 21-0105 |
Code Information |
Lot numbers M20689, 90299, 85047 |
Recalling Firm/ Manufacturer |
Deltec, Inc 1265 Grey Fox Road St Paul MN 55112
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For Additional Information Contact |
Michael Herbert 651-628-7049
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Manufacturer Reason for Recall |
Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
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FDA Determined Cause 2 |
Other |
Action |
A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive. |
Distribution |
The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FOZ and Original Applicant = PHARMACIA DELTEC, INC.
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