Device product
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Z-1324-2016
Product summary
- Event
- Event 73387
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,650 units
- Official record key
device-enforcement:Z-1324-2016
Official wording
Reason: Dialyzer header leak due to possible improper torque
Code information: Lot Number: 15KU04011 Exp. Date : 08/31/2013
Distribution pattern: US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.
Derived failure modes
-
Unknown
Dialyzer header leak due to possible improper torque