Z-0279-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- October 4, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,014 units
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.
Distribution Pattern
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.
Code Information
Product Code: 115269 (GTIN: 07332414117702), 955542 GTIN: 07332414124236); All Lot numbers