FDAFDA · Food and drugs·Recall number Z-1472-2021
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
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
- Lot Numbers: 4002486, 4019146, 4036647
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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