Z-1481-2021 Class II Terminated
FDA device recall Z-1481-2021 was initiated by Smiths Medical ASD Inc. on March 31, 2021 and is designated Class II. Reason for recall: 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 f… The recall status is terminated (terminated March 20, 2023). Affected quantity: 500 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- March 31, 2021
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 units
Product Description
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Reason for Recall
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.
Distribution Pattern
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Code Information
Lot Number 3946994