Recall Z-1543-2021— STEP-HAR MEDICAL LLC

Name: FDA recall Z-1543-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-26

Class I · Terminated

Class I FDA medical device recall by STEP-HAR MEDICAL LLC, initiated 2021-02-26, terminated 2024-08-15. It names one FDA 510(k) clearance: K133532. Product: Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part. Reason: 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..

Recalling firm: STEP-HAR MEDICAL LLC
Classification: Class I
Status: Terminated
Initiated: 2021-02-26
Terminated: 2024-08-15
Firm location: Fountain Valley, 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

Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical 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.

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