—#94872

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K970438
Affected lot / code info: product code 2N3410 and A2N3410 , all lots

Why it was recalled

If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Worldwide Distribution -- United States and Japan.

Timeline

Recall initiated: 2010-10-21
Posted by FDA: 2010-12-01
Terminated: 2011-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.