Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Reported: April 28, 2021 Initiated: March 31, 2021 #Z-1472-2021
Product Description
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
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
- 600 devices
- 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? ▼
Left Heart Kit, Model Number M20268. for blood pressure monitoring.. Recalled by Smiths Medical ASD Inc.. Units affected: 600 devices.
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-1472-2021.
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