Z-1869-2017 Class II Terminated
FDA device recall Z-1869-2017 was initiated by Elcam Medical, Inc. on February 2, 2017 and is designated Class II. Reason for recall: The stopcock was found to have punctures. The recall status is terminated (terminated June 8, 2018). Affected quantity: 810.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- February 2, 2017
- Termination Date
- June 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 810
Product 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 for Recall
The stopcock was found to have punctures.
Distribution Pattern
U.S Nationwide Distribution
Code Information
Lot #1670350901