FDA Enforcement
Class III
Terminated
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Recall: Z-0516-2019
·
Reported December 5, 2018
Enforcement
- Recall Number
- Z-0516-2019
- Event ID
- 81451
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 5, 2018
- Initiation Date
- October 9, 2018
- Classification Date
- November 29, 2018
- Termination Date
- August 5, 2021
- Address
- 920 Winter St, N/A, Waltham, MA, 02451-1521, United States
Description
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Reason
Discolored powder has confirmed the presence of a foreign substance
Code Info
Lot code:18ETGF005
Distribution
Distribution US nationwide and Mexico
Quantity
4752