Z-2837-2011

Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male...

Name: Z-2837-2011 Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male...
Creator: Baxter Healthcare Corp.
Published: 2011-07-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-07-06 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use... on 2011-07-06. The reason FDA records is "Some of the individual extension set packages were improperly sealed, compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2837-2011
Status: Terminated
Initiated: 2011-07-06
Posted: 2011-07-15
Terminated: 2012-04-18
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375 Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Baxter, sent an "Urgent Product Recall" letter dated July 6, 2011 via first class mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from their facility; call Baxter Healthcare's Center for Service at 1-888-229-0001 between 7:00 am and 6:00 pm Central Time, Monday through Friday to return affected product and receive credit; complete and return the attached CUSTOMER REPLY FORM to Baxter via fax at 1-847-270-5457 or scan and email to [email protected] and if you are a dealer, wholesaler or distributor/reseller, notify your customers of this recall. If you have questions regarding the communication, call 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: 9,800 sets
Distribution: Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.
Product codes and lots: product code 2N3375, lot number UR09H05029, expiration date 8/25/2014.

Product code FPA

K925126Class IIInterlink(tm) Injection SiteBaxter Healthcare Corp / cleared 1993-06-18

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)