Z-0081-2023 Class II Ongoing
FDA device recall Z-0081-2023 was initiated by Baxter Healthcare Corporation on Sep 14, 2022 and is designated Class II. Reason for recall: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient… The recall status is ongoing. Affected quantity: 524,376 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 19, 2022
- Initiation Date
- Sep 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 524,376 devices
Product Description
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
Reason for Recall
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Distribution Pattern
US Nationwide
Code Information
UDI: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0081-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026