FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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.
- Recall number
- Z-0587-2011
- Recalling firm
- Baxter Healthcare Corp.
- 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.
- Status
- Terminated
- Initiated
- 2010-10-28
- Posted
- 2010-12-09
- Terminated
- 2012-11-01
- Reason
- 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
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- all lots of product code 2C6202
- 510(k) numbers
- ["K962581"]
- PMA numbers
- not on file
- Product code
- FMG
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28