Z-0015-2013Class I

Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip...

Name: Z-0015-2013 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip...
Creator: Baxter Healthcare Corp.
Published: 2012-09-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2012-09-07 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway... on 2012-09-07. FDA classified it as Class I and gives the reason as "Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0015-2013
Classification: Class I
Status: Terminated
Initiated: 2012-09-07
Posted: 2012-10-09
Terminated: 2017-12-29
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter Healthcare Corp. sent an Urgent Product Recall letter dated September 7, 2012, via first class mail to all affected customers, informing them of the problem with the ball-valve, and instructing them to discontinue use of the affected product and to contact Baxter for instructions to return the affected product.. The customers 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. Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303.
Quantity in commerce: 488,504 units
Distribution: Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
Product codes and lots: product code 2H8819, all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0015-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0012-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09
Z-0013-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09
Z-0014-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09
Z-0015-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09

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)