Recall Z-0586-2011 ยท FMG Stopcock, I.V. Set
Baxter Healthcare Corp.
Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6201. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. The stopcock was sold alone and as a component of the following I.V. Administration Se
| Date | Dec 9, 2010 (initiated Oct 28, 2010) |
| Status | Terminated |
| 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 accou |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962581 | STOPCOCK MANIFOLD GANGS Baxter Healthcare Corp, Aug 28, 1996 |