Prismaflex Control Unit, software versions below 7.21
Reported: November 13, 2019 Initiated: October 4, 2019 #Z-0280-2020
Product Description
Prismaflex Control Unit, software versions below 7.21
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 336 units
- Distribution
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Prismaflex Control Unit, software versions below 7.21. Recalled by Baxter Healthcare Corporation. Units affected: 336 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0280-2020.
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