Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Reported: April 28, 2021 Initiated: March 31, 2021 #Z-1481-2021
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.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 500 units
- Distribution
- Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.. Recalled by Smiths Medical ASD Inc.. Units affected: 500 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Moderate. Recall number: Z-1481-2021.
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