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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System

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 Class 2 Device Recall Baxter Interlink Systemsee related information
Date Initiated by FirmDecember 18, 2002
Date PostedJanuary 16, 2003
Recall Status1 Terminated 3 on September 30, 2003
Recall NumberZ-0453-03
Recall Event ID 25247
510(K)NumberK881321 
Product Classification Set, Transfer (Blood/Plasma) - Product Code KSB
ProductInterlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 97'' long, 10 drops per mL plus Standard Bore 4-way Stopcock Extension Set, 35'' long, 5.2 mL volume, Male Luer Lock Adapter; Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information Lots GR182865, GR184309, GR186569
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCetenr for One Baxter
800-422 Ext. 9837
Manufacturer Reason
for Recall		Leakage may occur at the inlet port
FDA Determined
Cause 2		Other
ActionThe affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.
Quantity in Commerce6,724
DistributionNationwide
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = KSB
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