# FDA recall Z-2378-2021

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2021-07-22.

## Product

Baxter PrismaFlex, REF numbers:    a) 106696 (M 60 SET)  b) 106697 (M 100 SET)    Expansion:  c) 107144 (TPE2000 SET)  d) 115307 (M 150 SET)  e) 115309 (ST 100 SET)  f) 955467 (M 150 SET)  g) 955468 (ST 100 SET)  h) 955595 (M 100 SET)  i) 955596 (ST 150 SET)    Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

## Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.  "	Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter.  Data was manipulated to appear to be conforming

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2378-2021
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-22
- **Report date:** 2021-09-08
- **Termination date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2378-2021

## Citation

> AI Analytics. FDA recall Z-2378-2021. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-2378-2021. Source: US FDA. Licensed CC0.

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