Recall Z-1375-2021— Pacific Medical Group Inc.

Name: FDA recall Z-1375-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-24

Class I · Ongoing

Class I FDA medical device recall by Pacific Medical Group Inc., initiated 2021-03-24. It names one FDA 510(k) clearance: K133532. 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..

Recalling firm: Pacific Medical Group Inc.
Classification: Class I
Status: Ongoing
Initiated: 2021-03-24
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MXCarefusion 303, Inc.·cleared 2014-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.