| Date Initiated by Firm | March 29, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on December 28, 2006 |
| Recall Number | Z-0867-04 |
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| Recall Event ID |
28667 |
| 510(K)Number | K962695 |
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| Product Classification |
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
|
| Product | Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24 |
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| Code Information |
Lots M26963, M27058, and M27120 |
Recalling Firm/
Manufacturer |
Deltec, Inc
1265 Grey Fox Rd
Saint Paul MN 55112-6929
|
| For Additional Information Contact | Mike Herbert
651-628-7049 |
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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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Distribution | The recalled products were shipped nationwide in the United States and worldwide. |
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| 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.
|
| 510(K) Database | 510(K)s with Product Code = LJT
|
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