FDAFDA · Food and drugs·Recall number Z-1477-2021
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.
Published April 28, 2021 · Recall initiated: March 31, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
- Lot
- a. Model Number MX1431MR, Lot Numbers: 3995544 b. Model Number MX1431MRL, Lot Numbers: 3995545, 4011838, 4027758, 4033501, 4044959 c. Model Number MX4331R, Lot Numbers: 3971467, 3987918
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.