Z-1544-2021 Class I Ongoing
FDA device recall Z-1544-2021 was initiated by Infusion Pump Repair on March 26, 2021 and is designated Class I. Reason for recall: 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 o… The recall status is ongoing. Affected quantity: 15.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- March 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
Product Description
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Reason for Recall
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.
Distribution Pattern
California
Code Information
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