Z-1278-2022 Class I Terminated
FDA device recall Z-1278-2022 was initiated by Getinge Usa Sales Inc on May 2, 2022 and is designated Class I. Reason for recall: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction… The recall status is terminated (terminated Aug 6, 2024). Affected quantity: 17 units US.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 29, 2022
- Initiation Date
- May 2, 2022
- Termination Date
- Aug 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units US
Product Description
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Reason for Recall
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Distribution Pattern
US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Code Information
UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1278-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026