Recall Z-2939-2020— CareFusion 303, Inc.

Name: FDA recall Z-2939-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-04

Class I · Ongoing

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2020-08-04. It names one FDA 510(k) clearance: K133532. Product: BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.. Reason: Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2020-08-04
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

BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.

Reason for recall

Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.

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