FDA Device recall Z-1375-2021
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
- FDA Device
- Class I
- ongoing
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class I recall of Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions) by Pacific Medical Group, citing aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1375-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-03-24 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Pacific Medical Group |
| Distribution | US |
Product
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Reason
Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
Identifiers
| code_info | Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021: 4105026 4122780 9925856 9961244 12333241 12333419 1…Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021: 4105026 4122780 9925856 9961244 12333241 12333419 12333802 12334211 12334212 12334213 12334214 12334319 12334403 12334424 12334452 12334652 12334713 12334833 12334896 12334950 12334951 12334957 12335116 12335128 12335147 12335159 12335163 12335212 12335232 12335260 12335304 12335380 12335427 12335481 12335513 12335522 12335570 12335596 12335606 12335625 12335642 12335673 12335722 12335754 12335790 12335792 12335883 12335904 12335921 12335926 12335967 12335970 12336005 12336011 12336156 12336165 12336273 12336275 12336279 12336280 12336293 12336305 12336395 12336402 12336403 12336430 12336435 12336461 12336630 12336668 12336694 12336971 12337823 12421700 12517224 12524554 12524783 12544522 12568207 12570110 12570217 12571055 12580490 12586058 12586274 12586333 12587144 12588342 12590617 12590762 12591783 12591900 12592059 12592353 12592442 12592545 12592622 12592624 12592771 12592840 12592879 12592944 12592968 12592979 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1375-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.