CareFusion 303, Inc.: 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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba O.U.S.: Canada Quantity: 242,098 systems Lot/code info: Catalog Number: 8100 UDI-DI codes: 10885403810046 10885403517723 Software Version: 12.1.2 Serial/Lot Numbers: Pending

UPC codes

10885403810046, 10885403517723

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.