Infusion Pump Manual Instructs Users to Leave Safety Clamp Open
BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for an infusion pump where incorrect user instructions create a realistic risk of accidental over-infusion. No illnesses or injuries have been reported; the hazard is theoretical based on potential user error. This fits the rubric for High (3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The BD Alaris Pump Module, part of the BD Alaris System with Guardrails Suite MX, is a modular infusion pump used to deliver fluids to adult, pediatric, and neonatal patients. Approximately 242,098 systems are affected by this recall and were distributed across the U.S. (including all states and territories) and Canada.
CareFusion 303, Inc., is recalling the devices due to an error in the user manual and directions for use. The manual incorrectly instructs users to leave the safety clamp in the open position when reloading an infusion set. If users follow these incorrect instructions, the roller clamp may be left open, potentially resulting in accidental over-infusion.
No reports of illness or injury associated with this issue have been documented. The recalled devices include the BD Alaris Pump Module with catalog number 8100, software version 12.1.2, and select UDI-DI codes.
The recalled product
- Product
- 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 administra
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- mis-labeling
- over-infusion
Distribution
Distributed in 51 states:
- 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
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