Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile, nonpyrogenic fluid pathway; Baxter
FDA device recall Z-0586-2011 · posted 2010-12-09 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMG
- 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,
- Date initiated
- 2010-10-28
- Date posted
- 2010-12-09
- Date terminated
- 2012-11-01
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STOPCOCK MANIFOLD GANGS (K962581) | Baxter Healthcare Corp | 1996-08-28 |