Z-0474-2012

Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection...

Name: Z-0474-2012 Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection...
Creator: Baxter Healthcare Corp.
Published: 2011-12-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-12-06 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile... on 2011-12-06. The reason FDA records is "During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0474-2012
Status: Terminated
Initiated: 2011-12-06
Posted: 2012-01-11
Terminated: 2012-11-01
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 1C8621 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device
Product code: FPA Set, Administration, Intravascular
Reason for recall: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Baxter, sent an "Urgent Product Recall" letter dated December 6, 2011, via first class mail to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect all locations where their facility's inventory is located for products with the affected lot numbers; return the affected product; request a credit or replacement by calling Baxter Healthcare Center for Service at 1-888-229-0001 between 7:00am to 6:00pm Central time, Monday through Friday; complete and return the attached Customer Reply Form via fax to: 1-847-270-5457, or scan and email to [email protected]; and if they are a dealer, wholesaler, or distributor/reseller that distributed any affected product to other facilities, please notify their customers of this recall. If you have any questions regarding the communication, please 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: 4,272 units
Distribution: Worldwide distribution: USA (nationwide) including states of: Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Washington, Wisconsin and West Virginia; and country of: New Zealand.
Product codes and lots: product code 1C8621, lot numbers GR295352, GR296095 and GR296335

Product code FPA

K940867Class IIControl-a-Flo(tm) RegulatorBaxter Healthcare Corp / cleared 1994-05-05

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)