Z-0082-2023 Class II Ongoing
FDA device recall Z-0082-2023 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: 334,932 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 19, 2022
- Initiation Date
- Sep 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 334,932 devices
Product Description
Prismaflex M Set: M150 (product code 109990). 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 07332414090005; 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-0082-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026