FDA recall Z-0920-2020

Mindray DS USA, Inc. dba Mindray North America · Class II · device

Product

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))

Reason for recall

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.

Distribution

The products were distributed to the following US states: MI and TX.

Key facts

Status
Terminated
Initiation date
2019-12-09
Report date
2020-02-05
Termination date
2020-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0920-2020