| Class 2 Device Recall Baxter Interlink System Minivolume Extension Set | |
Date Initiated by Firm | July 06, 2005 |
Date Posted | August 06, 2005 |
Recall Status1 |
Terminated 3 on January 31, 2007 |
Recall Number | Z-1100-05 |
Recall Event ID |
32588 |
510(K)Number | K964850 |
Product Classification |
Set, Administration, Intravascular - Product Code FPA
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Product | Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol., with 0.22 Micron Downstream High Pressure Extended Life Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. |
Code Information |
product code 1C8462, lots GR219444, GR223255, GR224659, GR227140; |
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 |
Manufacturer Reason for Recall | Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway. |
FDA Determined Cause 2 | Other |
Action | Baxter sent Urgent Product Recall letters dated 7/6/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the complaints of leaks and disconnection between the bifurcated Y-site and the set tubing, resulting in the possible under delivery of medication, blood loss and a breach of the sterile fluid pathway. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. |
Quantity in Commerce | 4,176 sets |
Distribution | Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina 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 = FPA
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