Shape-HF Cardiopulmonary Testing System Disposable recall
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing…
Why was Shape-HF Cardiopulmonary Testing System Disposable recalled?
This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.
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: 1412001, 1412002, 1412003 and 1412004
- Product
- Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing…
- Recalling firm
- Shape Medical Systems, Inc
- Quantity
- 564 devices
- Distribution
- Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
- Recall date
- February 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)