FDAFDA · Food and drugs·Recall number Z-1480-2021
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
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. REF 601280, Lot Numbers: 3872300, 3946984 b. REF 601281, Lot Numbers: 3872301, 4024481
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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