Recall Z-1869-2017 ยท FMG Stopcock, I.V. Set
Elcam Medical, Inc.
Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
| Date | Feb 2, 2017 |
| Status | Terminated |
| Reason | The stopcock was found to have punctures. |
| Root cause | Package design/selection |
| Action | Elcam Medical sent their customers a recall letter/return response form dated February 2, 2017. Elcam is asking customers to examine their inventory for any affected products and to complete the return response form provided. For questions call 201-457-1120 ext. 102 or 201-457-1120 ext. 112. |
| Quantity | 810 |
| Distribution | U.S Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK Elcam Medical Acal, Apr 13, 2006 |