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.
FDA Recall Z-1869-2017 · Posted None
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Recalling FirmElcam Medical, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2017-02-02
Date Terminated2018-06-08
Product Quantity810
Reason for Recall
The stopcock was found to have punctures.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
U.S Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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