Class III — Michigan Instruments, Inc.
| Recalling firm | Michigan Instruments |
|---|---|
| Registered facility | MICHIGAN INSTRUMENTS (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last to revolution of the knob could deliver a full 8cm of compression. |
| 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. |
| Quantity | 38 devices |
| Distribution | Distributed to China. |
| Initiated | 2018-02-13 |
| Classified | 2018-05-04 |
| Terminated | 2019-04-03 |
| Recall number | Z-1632-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Michigan Instruments, Inc. (Z-1632-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79764/
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