FDAFDA · Food and drugs·Recall number Z-1544-2021
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Published May 19, 2021 · Recall initiated: March 26, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Infusion Pump Repair
- Distributor
- California
- Lot
- Devices distributed between 01/15/2021 and 03/14/2021. Sale Order #/Serial #: 1599930872/ 12335834, 13617863, 13447266, 13089105, 12333728, 13616451, 13618575, 12729374; 82943/ 4122252, 4122320; 01112101A/ 12638236, 13813590, 12639090, 13744738, 9951014
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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