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Class 2 Device Recall MiniCap with ProvidoneIodine solution |
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Date Initiated by Firm |
May 21, 2013 |
Date Posted |
June 21, 2013 |
Recall Status1 |
Terminated 3 on July 14, 2016 |
Recall Number |
Z-1565-2013 |
Recall Event ID |
65254 |
510(K)Number |
K895631
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Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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Product |
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Intended to isolate the Easy-Lock connector of the solution transfer set. |
Code Information |
Lot Number GD893891 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
leaking pouches
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FDA Determined Cause 2 |
Packaging change control |
Action |
The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837. |
Quantity in Commerce |
629,280 units |
Distribution |
Nationwide Distribution. |
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 = KDI and Original Applicant = BAXTER HEALTHCARE CORP.
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