FDA Enforcement
Class II
Terminated
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Recall: Z-1324-2016
·
Reported April 13, 2016
Enforcement
- Recall Number
- Z-1324-2016
- Event ID
- 73387
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 13, 2016
- Initiation Date
- February 26, 2016
- Classification Date
- April 5, 2016
- Termination Date
- June 26, 2017
- Address
- 920 Winter St, N/A, Waltham, MA, 02451-1521, United States
Description
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Reason
Dialyzer header leak due to possible improper torque
Code Info
Lot Number: 15KU04011 Exp. Date : 08/31/2013
Distribution
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.
Quantity
1,650 units