Z-1967-2021 Class II Terminated
FDA device recall Z-1967-2021 was initiated by Spes Medica on April 8, 2021 and is designated Class II. Reason for recall: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. The recall status is terminated (terminated May 10, 2022). Affected quantity: 20 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- April 8, 2021
- Termination Date
- May 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 boxes
Product Description
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
Reason for Recall
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Distribution Pattern
Distribution in the following US states: CA, MA, and SC.
Code Information
Lot LS20G3274I