Haemofilter
- Recalling firm
- Vantive Limited
- Product
- Haemofilter. [Device]. Model: Prismaflex ST100 and Prismaflex ST150 - Product code 107636, 107640; Prismaflex TPE2000 - Product code 107144; Oxiri - Product code 97003; (Oxiris). Affected: Prismaflex ST100 - All lots including and manufactured after 24F0069. Prismaflex ST150 - All lots including and manufactured after 24E0059; All lots including and manufactured after 24E0067CB; All lots including and manufactured after 24F0087. Also covers: Meyzieu TPE sets; oXiris Set - EU MDR; oXiris Set - EUMDR - Vantive
- Reason
- The manufacturer is notifying Prismaflex Control Unit users of a potential risk of the Prismaflex Set deaeration chamber becoming dislodged during use. This issue does not affect PrisMax Control Units and may only occur when Prismaflex Sets are used with the Prismaflex Control Unit, as the two systems have different deaeration chamber holder designs.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-26
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/725dabe1-a299-410c-8a23-dcbad2f1749d