Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BD Alaris Pump Module REF 8100 The BD Alaris System Recalled by CareFusion 303, Inc. Due to Due to User Manual/Direction for Use incorrectly instructing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CareFusion 303, Inc. directly.
Affected Products
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration
Quantity: 242,098 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 49 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, DC
About CareFusion 303, Inc.
CareFusion 303, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report