CareFusion 303, Inc. recalled BD Alaris System PC Unit Model 8100 pump modules and replacement kits worldwide on Aug. 4, 2020, according to the FDA. The hazard involves unresponsive or stuck keypad keys that may delay or interrupt infusion, potentially causing serious injury or death.
How to tell if you have it
- BD Alaris System PC Unit Model 8100 (Pump Module), all serial numbers
- Pump Module Door Assembly Replacement Kits, P/N 49000239, 49000346, 49000438, 49000439
The hazard
The Pump Module keypad may exhibit keys that are unresponsive or stuck due to fluid ingress. This defect can result in a delay to the start of infusion or an interruption of infusion. Delays or interruptions can cause serious injury or death in high-risk patient populations.
Context
GovInfoNow's records show CareFusion 303, Inc. has had 64 other recalls since June 12, 2017. Recent brand recalls include a BD Pyxis MedStation ES Tower 352 Medication Cabinet recall on April 30, 2026, for overheating fingerprint scanners, and a CareFusion labeling recall on Feb. 11, 2026, regarding TLS version indicators. Other recent recalls of similar products include a BD Alaris Pump Infusion Sets Recall on Aug. 19, 2026, for performance data discrepancies, and a Baxter Novum IQ Syringe Pump Recall on Aug. 11, 2026, for software issues.