Reported Mar 31, 2021 · Terminated

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Prismaflex Control Unit - Product UsageUsed for Continuous Renal Replacement Therapy (CRRT)
Lot codes and dates
  • 4,069 of 4,069 codes

    • GTIN 07332414073718 (Product code 107493)
    • serial numbers PA0105
    • PA0104
    • PA0106
    • PA0102
    • PA0107
    • PA0112
    • PA0111
    • PA0117
    • PA0113
    • PA0120
    • PA0127
    • PA0124
    • PA0130
    • PA0132
    • PA0131
    • PA0134
    • PA0128
    • PA0136
    • PA0141
    • PA0140
    • PA0143
    • PA0142
    • PA0148
    • PA0149
    • PA0147
    • PA0153
    • PA0152
    • PA0150
    • PA0163
    • PA0162
    • PA0160
    • PA0159
    • PA0158
    • PA0165
    • PA0164
    • PA0177
    • PA0176
    • PA0169
    • PA0167
    • PA0166
    • PA0180
    • PA0179
    • PA0184
    • PA0178
    • PA0188
    • PA0186
    • PA0195
    • PA0199
    • PA0211
    • PA0216
    • PA0214
    • PA0209
    • PA0205
    • PA0216
    • PA0204
    • PA0222
    • PA0217
    • PA0226
    • PA0231
Amount recalled
4946 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 13, 2024 · Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.