Z-0587-2011

Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pathway; Baxter...

Name: Z-0587-2011 Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pathway; Baxter...
Creator: Baxter Healthcare Corp.
Published: 2010-10-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2010-10-28 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product... on 2010-10-28. The reason FDA records is "Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy". 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-0587-2011
Status: Terminated
Initiated: 2010-10-28
Posted: 2010-12-09
Terminated: 2012-11-01
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6202. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Product code: FMG Stopcock, I.V. Set
Reason for recall: Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy.
Root cause tag: design
FDA root cause: Device Design
Action: Safety Alert letters dated October 28, 2010 were mailed via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, on the same date, informing them that rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy. The accounts were requested to post the enclosed attachment, which illustrates the correct direction to turn the handle of the stopcock, where the stopcocks/sets are dispensed. The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at (847) 270-5457. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 10/27/10, and instructed to notify their customers and ministries of health of the recall. 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.
Distribution: Worldwide distribution: USA and countries including Puerto Rico, Guam and American Samoa, and internationally to Canada, Bermuda, Jamaica, Guatemala, Panama, Bahrain, United Kingdom, Hungary, Lebanon, Pakistan, Saudi Arabia and New Zealand.
Product codes and lots: all lots of product code 2C6202

Product code FMG

K962581Class IIStopcock Manifold GangsBaxter Healthcare Corp / cleared 1996-08-28

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)