Z-1360-2020 Class I Ongoing
FDA device recall Z-1360-2020 was initiated by CareFusion 303, Inc. on February 4, 2020 and is designated Class I. Reason for recall: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping … The recall status is ongoing. Affected quantity: 1286898.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- February 4, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1286898
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.