Z-2708-2011

Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use...

Name: Z-2708-2011 Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use...
Creator: Baxter Healthcare Corp.
Published: 2011-05-31
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-05-31 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series... on 2011-05-31. The reason FDA records is "The lot of Baxter Solution Set for Epidural Use is 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...". 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-2708-2011
Status: Terminated
Initiated: 2011-05-31
Posted: 2011-06-29
Terminated: 2012-06-18
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxter Healthcare corporation, Deerfield, IL; product code 2C7554s The tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for periods up to 96 hours.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The lot of Baxter Solution Set for Epidural Use is 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 sent Urgent Product Recall letters dated May 31, 2011, via UPS overnight delivery to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also 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. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 5/31/11, and instructed to notify their customers and ministries of health of the recall. *** The recall was expanded to include two additional lots of product code 2C7554s on July 11, 2011 via letter of the same date. The recall strategy remains the same as that of May 31, 2011. ***
Quantity in commerce: 13,920 units
Distribution: Worldwide Distribution - USA including Alabama, Arizona, California, Illinois, Kentucky, Louisiana, New Mexico, North Carolina, Ohio, Oregon, Tennessee and Washington, and internationally to Canada and South Africa.
Product codes and lots: product code 2C7554s, lot GR293209 *** The recall was expanded to include lots GR291559 and GR294928 ***

Product code FPA

K925058Class IIBard Ambu Pump Spik Tub Set Pacret Provid Pump SetC.R. Bard, Inc. / cleared 1993-08-03

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)