BD Alaris recalls infusion pump modules with faulty keypads that may cause unresponsive keys, leading to medication infusion errors. Affected units were manufactured from January 2019 to December 2019. Contact for replacement.
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
Take action
Contact the company
📍Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
“BD Alaris Infusion Pump Module Keypad Recall: Unresponsive Keys Risk Medication Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63170-bd-alaris-infusion-pump-module-keypad-recall-unresponsive-keys-risk. Based on FDA recall #Z-1309-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1309-2021%22&limit=1).
CareFusion 303, Inc. recalled BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad and related replacement kits due to keypad lifting and fluid ingress hazards that may cause unresponsive or stuck keys. The FDA announced the voluntary Class I recall on March 3, 2021.
How to tell if you have it
Brand: BD Alaris
Product: Model 8100 Pump Module Keypad; Pump Module Door Assembly Replacement Kit with Pump Module Keypad
Parts: 49000239; 49000346; 49000438; 49000439
Pump Module with Keypad manufactured January 23, 2019 to December 5, 2019
Pump Module Door Assembly Kit with Keypad dated January 15, 2019 to November 14, 2019
The hazard
According to the FDA, Pump Module keypad lifting and fluid ingress could result in unresponsive keys where the module continues infusion without alarming, or stuck keys causing channel errors and infusion interruption. These issues may necessitate a different Pump Module or result in infusion start delays and an inability to titrate medication.
Context
GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since June 12, 2017. Other recent recalls of similar products include BD Pyxis Mini Main REF 349 Medication Cabinet (April 30, 2026), CareFusion TLS labeling issue (Feb. 11, 2026), and BD Pyxis ES Enterprise Server Software Update Issue (Dec. 3, 2025). Other recent recalls of similar products include BD Alaris Pump Infusion Sets (Aug. 19, 2026), Baxter Novum IQ Syringe Pump (Aug. 11, 2026), and Fresenius Kabi LVP-0004 Infusion Pump (Feb. 4, 2026).
How to tell if you have this one
Check for the model number 8100 on the pump module keypad. Affected units were manufactured between January 23, 2019, and December 5, 2019. Replacement kits were sold from January 15, 2019, to November 14, 2019.
Brand
BD Alaris
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the affected infusion pump module to prevent medication errors.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1309-2021 (March 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1309-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.