CLASS II ONGOING Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
Prismaflex Control Unit recalled by Baxter Healthcare
Baxter Healthcare is recalling Prismaflex Control Unit, distributed nationwide in the US. The recall was initiated on 4 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0277-2020
- FDA event ID
- 83852
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Oct 2019
- FDA classified
- 4 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 4 Oct 2019 | Recall initiated by company | |
| 4 Nov 2019 | Classified by FDA | +31 days |
| 13 Nov 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Prismaflex Control Unit, software versions below 7.21
Where it was distributed
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia, Macau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Prismaflex Control Unit recalled?
Yes. Baxter Healthcare recalled Prismaflex Control Unit on 4 Oct 2019. The recall is Class II and its status is Ongoing. Recall number Z-0277-2020.
Why was it recalled?
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Which lots are affected?
Product Code: 113081; All Lot numbers; GTIN: 07332414105266
Where was it sold?
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia, Macau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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