Z-0199-06

Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball...

Name: Z-0199-06 Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball...
Creator: Baxter Healthcare Corp.
Published: 2005-03-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-03-17 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter... on 2005-03-17. The reason FDA records is "The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0199-06
Status: Terminated
Initiated: 2005-03-17
Posted: 2005-11-26
Terminated: 2008-03-04
Recalling firm: Baxter Healthcare Corporation
Product: Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A
Product code: FPA Set, Administration, Intravascular
Reason for recall: The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Urgent Device Correction letters dated 3/17/05 were sent to the direct accounts via first class mail on 3/17/05, to the attention of the director of nursing. The letters informed the accounts that there is a potential for a non-detection of an upstream occlusion under certain conditions if the product codes 2C7546(S) and 2C7566(S) Buretrol Solution Sets are used with the Colleague Infusion Pumps. Baxter recommends that these product codes no longer be used with the Colleague pumps, and listed product codes 2C7519(S) and 2C7564(S) as alternative compatible sets that can be used with the Colleague pumps. Any questions concerning the compatibility of other Buretrol sets with the Colleague pumps were directed to Baxter Medication Delivery Product Information Center at 1-800-933-0303. Since teh two product codes are no longer recommended for COlleague pumps, the accounts were given the choice of returning their stocks of the two product codes for credit and order an alternative by calling Baxter Healthcare Center for Service at 1-888-229-0001. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 7,507,494 sets
Distribution: Nationwide, including Puerto Rico and American Samoa, and internationally to Japan, Mexico, Australia, New Zealand, Hong Kong, Singapore, Switzerland, China, Uruguay, East Timor, Armenia and Panama.
Product codes and lots: all lots of product codes 2C7546(S) and 2C7566(S), as well as A2C7572, A2C9568 and A2C9584 for the Australian market, JC7566 for the Canadian market, and VMC9602P for the European market.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)