Z-2920-2011

Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare...

Name: Z-2920-2011 Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare...
Creator: Baxter Healthcare Corp.
Published: 2011-07-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-07-21 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic... on 2011-07-21. The reason FDA records is "The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be...". 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-2920-2011
Status: Terminated
Initiated: 2011-07-21
Posted: 2011-08-03
Terminated: 2012-06-18
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Baxter Healthcare Corporation sent a "Urgent Product Recall" letter dated July 21, 2011 to all affected customers. The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers. For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
Quantity in commerce: 4,752 units
Distribution: (USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.
Product codes and lots: Product Code 1C8507s, lot numbers GR291542, GR292409, GR292797 and GR294454.

Product code FPA

K961225Class IIContinuflo Solution Set/secondary Medication SetBaxter Healthcare Corp / cleared 1996-06-21

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)