LogiCal Left Heart Kit recall
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Why was LogiCal Left Heart Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 3995542, 4002489, 4016473, 4048833,4069387
- Product
- LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 3740 devices
- Distribution
- Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)