Medical device recalls

Michigan Instruments, Inc. recalls Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Car…

Recall date
February 13, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1632-2018
FDA classification
Class III
Brand / firm
Michigan Instruments, Inc.
Sold / distributed
Distributed to China.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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