U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Medical Device Recalls
  5. Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion
  1. Medical Device Recalls

Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

  • Alaris Pump Module Model 8100 Bezel Assembly:
    • Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 that include bezels manufactured with a type of plastic called FR-110.
    • Alaris Pump Modules serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203)
    • Alaris Pump Module Bezel Kit Assembly (P/N 10964559 and P/N 49000204).
  • Model Number: Model 8100
  • Manufacturing Dates: April 2011 to June 2017*
  • Distribution Dates: April 2011 to June 2017
  • Devices Recalled in the U.S.: 586,345
  • Date Initiated by Firm: Ongoing since the original recall dated July 1, 2017*

* This product was initially recalled on August 9, 2017 (FDA Recall # Z-0026-2018).  The firm subsequently expanded the recall on April 13, 2018 to expand the volume of product impacted.  On February 1, 2019, BD further expanded the recall to include all Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017.

Device Use

The Alaris Pump Module is an infusion pump that delivers fluids including medications, blood and blood products, into a patient's body in controlled amounts. The pump administers fluids via an infusion tubing set into a patient's vein or through other cleared routes of administration. There are six bezel posts that connect the pumping mechanism frame to the bezel assembly and are critical to proper performance of the pump. The device is used in hospitals and other health care facilities

1)Two pump modules with attached Alaris PC unit. 2) Pump module door open showing the front of the bezel. 3) Back side of bezel assembly highlighting the bezel posts.

1)Two pump modules with attached Alaris PC unit. 2) Pump module door open showing the front of the bezel. 3) Back side of bezel assembly highlighting the bezel posts.

Reason for Recall

The bezel posts may become cracked and separated which could lead to inaccurate delivery of fluids to the patient. From 2011-2017, the Alaris Pump Module Model 8100 was manufactured with a type of plastic called FR-110. The manufacturing process for the FR-110 plastic resulted in weakening of the plastic, which may lead to separation of the bezel post from the pumping mechanism or other damage to the bezel, such as cracking. Separation or cracking of bezel posts may lead to over-infusion, under-infusion, free-flow state, or interruption of infusion.

This recall has been associated with MDR reports, several of which are associated with serious injuries.

Who May be Affected

  • Patients of all ages receiving fluids, medications, blood, or blood products using the Alaris Pump Module Model 8100

What to Do

BD CareFusion 303, Inc., issued an updated communication on July 18, 2019 to amend the customer notification letter issued on April 15, 2019, which states that BD is contacting customers affected by the recall to schedule inspection and replacement of bezel assemblies. Customers should follow the instructions in the recall notification for inspection of their pumps. Until the bezels affected by this recall are replaced, customers should inspect bezels as soon as feasible. If damage is found during the inspection, the pump should be removed from service and BD should be contacted for replacement bezels. In addition, the notification stated: 

  • Customers should contact the BD Support Center to coordinate training on the bezel inspection process.
    • For inspection instructions, refer to Service Bulletin 621 or watch the bezel inspection training video on BD's website.

BD's website provides additional support for customers affected by this recall.

4) Bezel post with no separation (left) and bezel post with separation (right).

4) Bezel post with no separation (left) and bezel post with separation (right).

Contact Information

For general follow-up or recall related questions, please contact BD Support Center:

Additional Resources

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX to 1-800-FDA-0178.

More Information