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Class 2 Device Recall Interlink |
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Date Initiated by Firm |
July 16, 2003 |
Date Posted |
August 21, 2003 |
Recall Status1 |
Terminated 3 on June 29, 2004 |
Recall Number |
Z-1151-03 |
Recall Event ID |
26772 |
510(K)Number |
K811463 K881052 K925126 K953098
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Product Classification |
Set, Administration, Intravascular - Product Code FPA
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Product |
Interlink System Solution Set with Microbore Tubing, 60 Drops/mL, 123'', 2 injection sites, Male Luer Lock Adapter, catalog 2C6426; Baxter Healthcare Corporation, Deerfield, IL 60015 USA |
Code Information |
catalog 2C6426, lot number UR146407 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
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FDA Determined Cause 2 |
Other |
Action |
Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product. |
Quantity in Commerce |
6,192 units |
Distribution |
Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan |
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 = FPA and Original Applicant = BAXTER HEALTHCARE CORP.
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