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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System Buretrol Solution Set

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 Class 2 Recall
Baxter Interlink System Buretrol Solution Set
see related information
Date Posted October 15, 2010
Recall Status1 Terminated on February 25, 2011
Recall Number Z-0070-2011
Recall Event ID 56699
Premarket Notification
510(K) Number
K984381 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set, 38" (97 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, 60 DPM; a sterile Rx IV fluid pathway device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0166 The administration of fluids from a container into the patient's vascular system through a vascular access device
Code Information product code 3C0166, lot GR288365
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
There are leaks in the Drip Chamber Check Valve Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Baxter sent an "Urgent Product Recall" letter dated September 2, 2010, via first class mail to the direct account, to the attention of the Director of Materials Management, with a copy sent to the Director of Nursing, on the same date, informing them that leaks were detected in the Drip Chamber Check Valve Subassembly used in the affected lot of Interlink System Buretrol Solution Sets. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection. The account was requested to examine their inventory in all locations to determine if they have any of the affected lot and remove the affected product from inventory; call Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
Quantity in Commerce 948 units
Distribution Nationwide distribution: Wisconsin only.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = BAXTER HEALTHCARE CORP.
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