CareFusion 303, Inc. 2025-03-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1231-2025
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a… Recall
Issued March 5, 2025 · CareFusion 303, Inc.
In March 2025, CareFusion 303, Inc. recalled the BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
What you should do
- 1 Stop using BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact CareFusion 303, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- CareFusion 303, Inc.
- Category
- Health
- Recall date
- March 5, 2025
- Units affected
- Not reported
- Sold at
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM
- Recall number
- FDA-Z-1231-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- CareFusion 303, Inc. has 13 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.