Z-0081-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2022
- Initiation Date
- September 14, 2022
- Termination Date
- N/A
- 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