Wixom, MI, United States
Rockwell Medical, Inc recalls
1 recall recorded since 2018, most recently on 7 April 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 April 2018
- Terminated
- 1 October 2018
- Reason
- A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
- Distribution
- US Distribution to the state of NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1869-2018
- DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrat
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.