Z-2208-2023 Class II Ongoing
FDA device recall Z-2208-2023 was initiated by Baxter Healthcare Corporation on Jun 19, 2023 and is designated Class II. Reason for recall: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the… The recall status is ongoing. Affected quantity: 122 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 26, 2023
- Initiation Date
- Jun 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122 units
Product description
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Reason for recall
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
Distribution pattern
US
Code information
GTIN 00844735006148, all serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2208-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026