Recall Z-2623-2011 ยท FMG Stopcock, I.V. Set
Baxter Healthcare Corp.
Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
| Date | Jun 22, 2011 (initiated May 17, 2011) |
| Status | Terminated |
| Reason | There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product. |
| Root cause | Package design/selection |
| Action | Baxter Urgent Product Recall letters dated May 17, 2011 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 potential pinholes and tears in the individual packaging could compromise the sterility of the stopcock. The accounts were requested to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also reques |
| Quantity | 4,800 units |
| Distribution | California and internationally to Japan and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962581 | STOPCOCK MANIFOLD GANGS Baxter Healthcare Corp, Aug 28, 1996 |