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Recall Observatory FDA recall evidence

Device product

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.

Z-1869-2017

February 02, 2017

Class II

Product summary

Firm
Elcam Medical, Inc.
Event
Event 76446
Status
Terminated
Classification
Class II
Quantity
810
Official record key
device-enforcement:Z-1869-2017

Official wording

Reason: The stopcock was found to have punctures.

Code information: Lot #1670350901

Distribution pattern: U.S Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The stopcock was found to have punctures.