Z-0920-2020 Class II Terminated
FDA device recall Z-0920-2020 was initiated by Mindray DS USA, Inc. dba Mindray North America on December 9, 2019 and is designated Class II. 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 fin… The recall status is terminated (terminated September 17, 2020). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- December 9, 2019
- Termination Date
- September 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
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 Pattern
The products were distributed to the following US states: MI and TX.
Code Information
Serial Numbers: W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, W1-85000011