Michigan Instruments Recalls Thumper Cardiopulmonary Resuscitator Due to Valve Defect
Michigan Instruments is recalling 38 Thumper Cardiopulmonary Resuscitators because a valve defect may prevent the device from delivering chest compression depth.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The defect is a performance issue where the device may not function as intended, but no injuries or illnesses are reported in the source text.
Plain-English summary
Michigan Instruments, Inc. is recalling 38 units of the Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370. The device is used to perform cardiopulmonary resuscitation (CPR) on adult patients in cases of clinical death. The affected units were distributed to China.
The recall is due to a performance issue with the chest depth needle valve (CDNV). This defect may cause the device to fail to deliver any compression depth to the piston during the first five revolutions of the adjustment knob. Additionally, the final fraction of a revolution of the knob could deliver a full 8cm of compression, which may not be the intended setting.
The source text does not specify the corrective action or instructions for consumers. The recall number is Z-1632-2018.
The recalled product
- Product
- Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
- Manufacturer
- Michigan Instruments, Inc.
- Hazard
- Affected units
- 38
Distribution
Distribution scope not specified by the agency.
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