Medical device recalls Moderate risk

Mindray DS USA, Inc. dba Mindray North America recalls BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Mat…

Recall date
December 9, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0920-2020
FDA classification
Class II
Brand / firm
Mindray DS USA, Inc. dba Mindray North America
Sold / distributed
The products were distributed to the following US states: MI and TX.

Why it was recalled

The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

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

What was recalled

BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

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