Device product
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Z-0085-2023
Product summary
- Event
- Event 90841
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29,764 devices
- Official record key
device-enforcement:Z-0085-2023
Official wording
Reason: 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.
Code information: UDI 07332414089443, All Lot Codes
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.