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Fenwal Inc FDA Recalls
5 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platformClass IIFeb 14, 2023Potential for centrifuge packs to develop a stress leak for |
| Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platformClass IIFeb 14, 2023Potential for centrifuge packs to develop a stress leak for |
| Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.Class IIFeb 25, 2021Some lots of Amicus MNC Apheresis and Amicus Exchange kits h |
| Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and monClass IIFeb 25, 2021Some lots of Amicus MNC Apheresis and Amicus Exchange kits h |
| Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclearClass IIFeb 25, 2021Some lots of Amicus MNC Apheresis and Amicus Exchange kits h |