Z-0487-2010

Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber...

Name: Z-0487-2010 Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber...
Creator: Baxter Healthcare Corp.
Published: 2009-11-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2009-11-03 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer... on 2009-11-03. The reason FDA records is "The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use". 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-0487-2010
Status: Terminated
Initiated: 2009-11-03
Posted: 2009-12-09
Terminated: 2010-07-08
Recalling firm: Baxter Healthcare Corporation
Product: Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An "Urgent Product Recall" letter dated November 3, 2009 was sent to the direct accounts via first class mail on the same date, to the attention of the Director of Nursing and the Director of Materials Management. The letter informed the accounts that there have been reports of a separation of the tubing from the distal Clearlink Y-site of the set, with one instance resulting in a serious injury. The accounts were instructed to examine their inventory and remove any sets of Product code 2C8864, Lot number UR09E21238 from inventory and return the affected product for credit or replacement product by calling Baxter Healthcare Center for Service at 1-888-229-0001, Prompt 2, during hours of operation 7:00 a.m. to 6:00 p.m. Central Standard Time. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. If the accounts further distributed the Buretrol Sets, they were requested to forward the communication to those accounts. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter.
Quantity in commerce: 173 cases
Distribution: Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada and New Zealand.
Product codes and lots: Product code 2C8864; Lot number UR09E21238.

Product code FPA

K984381Class IIBuretrol Solution SetsBaxter Healthcare Corp / cleared 1999-02-19

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)