Recall Z-2736-2020— CareFusion 303, Inc.

Name: FDA recall Z-2736-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Class I · Terminated

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2020-06-30, terminated 2024-04-23. It names one FDA 510(k) clearance: K133532. Product: Alaris Pump Module Model 8100. Reason: Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Terminated
Initiated: 2020-06-30
Terminated: 2024-04-23
Firm location: San Diego, 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

Reason for recall

Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.

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