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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System MicroInfusion Manifold

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 Class 2 Recall
Baxter Interlink System MicroInfusion Manifold
see related information
Date Posted December 01, 2010
Recall Status1 Terminated on October 16, 2011
Recall Number Z-0502-2011
Recall Event ID 56892
Premarket Notification
510(K) Number
K970438 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product code 2N3410 and A2N3410 - Japan Baxter Healthcare corporation, Deerfield, IL 60015 USA; Intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions.
Code Information product code 2N3410 and A2N3410 , all lots
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Baxter sent an "Urgent Device Correction" letter dated October 20, 2010, via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, informing them that there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. The loosening or disconnection can result in an interruption of therapy, potentially resulting in patient injury and death. The accounts were requested to place the notification where the inventory of affected product is dispensed, so that users are made aware of the procedures to follow: "If these devices are connected in series, and the luer connector is tightened, do not twist the manifolds. This may lead to loosening or disconnection, which may cause a leak. Additionally, Baxter recommends checking all connections before starting and during infusion therapy." The accounts were requested to 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 752,965 units in US and all lots in Japan
Distribution Worldwide Distribution -- United States and Japan.
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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