Medical device recalls Moderate risk

Cook Inc. recalls Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells…

Recall date
March 22, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1460-2018
FDA classification
Class II
Brand / firm
Cook Inc.
Sold / distributed
Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.

Why it was recalled

Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

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