Recall Z-1651-2021— The Biomed Guys

Name: FDA recall Z-1651-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-25

Class I · Ongoing

Class I FDA medical device recall by The Biomed Guys, initiated 2021-03-25. It names one FDA 510(k) clearance: K133532. Product: Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.. Reason: Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion..

Recalling firm: The Biomed Guys
Classification: Class I
Status: Ongoing
Initiated: 2021-03-25
Firm location: Clarksville, TN, 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

Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

Reason for recall

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. 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.