Z-1199-2018 Class II Terminated
FDA device recall Z-1199-2018 was initiated by GE Healthcare, LLC on October 4, 2017 and is designated Class II. Reason for recall: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. The recall status is terminated (terminated April 10, 2020). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- October 4, 2017
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Reason for Recall
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Distribution Pattern
US Distribution to states of: AZ, IL NC, NH and PA.
Code Information
Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187