Overview of recall records associated with Fenwal Inc., including dates, categories and classifications where available.
Classification mix: Class II: 7, Class I: 2.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and…
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and…
Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result…
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
This page summarizes recall records in which the official source identifies Fenwal Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
