CareFusion 303, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1309-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.

Product Classification:

Class I

Date Initiated: March 3, 2021

Date Posted: April 7, 2021

Recall Number: Z-1309-2021

Event ID: 87387

Reason for Recall:

Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay

Status: Ongoing

Product Quantity: 160300

Code Information:

Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019.

Distribution Pattern:

Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ

Voluntary or Mandated:

Voluntary: Firm initiated