FDA Recall
Terminated
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.
Recall: Z-1869-2017
·
Initiated February 2, 2017
Recall
- Recall Number
- Z-1869-2017
- Event Number
- 76446
- Firm
- Elcam Medical, Inc.
- FEI Number
- 3003649401
- Product Code
- FMG
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- February 2, 2017
- Terminated
- June 8, 2018
- Address
- 2 University Plz, Ste 620, Hackensack, NJ, 07601-6224
Description
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.
Reason
The stopcock was found to have punctures.
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.
Distribution
U.S Nationwide Distribution
Quantity
810