Z-0502-2011

Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3...

Name: Z-0502-2011 Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3...
Creator: Baxter Healthcare Corp.
Published: 2010-10-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2010-10-21 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL... on 2010-10-21. The reason FDA records is "If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0502-2011
Status: Terminated
Initiated: 2010-10-21
Posted: 2010-12-01
Terminated: 2011-10-16
Recalling firm: Baxter Healthcare Corporation
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.
Product code: FPA Set, Administration, Intravascular
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 root cause: Other
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.
Product codes and lots: product code 2N3410 and A2N3410 , all lots

Product code FPA

K970438Class IIInterlink Micro-Infusion Manifold Extension SetsBaxter Healthcare Corp / cleared 1997-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)