Manufacturer Recalls: Alaris Medley 8100 Bezel

Last Edited Date: July 1, 2019

Alaris Pump Module Model 8100 Bezel Post Separation Recall

Becton Dickinson (BD) is announcing a recall expansion of the Alaris™ Pump Module to include all bezels manufactured between April 2011 and June 2017. All of the bezels subject to this recall expansion were manufactured with a specific type of plastic, called FR-110.

Issue

The component of the Alaris Pump module that is the subject of this recall is the bezel assembly, and the issue involves potential separation of the bezel posts. The bezel has 6 posts that connect the pumping mechanism frame to the bezel assembly and are critical to the proper performance of the pump. BD’s ongoing investigation has determined that the bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post

(recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts is a potential safety concern and, therefore, BD is initiating this voluntary recall.

Affected Products

The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.

  • Alaris™ Pump Modules Model 8100 manufactured between April 2011 and June 2017 that include FR-110 bezels.
  • 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).

If you have any questions regarding the products, please contact:

BD Support Center

Phone: 888-562-6018

Phone hours: 7:00 am to 4:00 pm PT, Monday – Friday

Email: SupportCenter@bd.comGeneral Follow-up or Recall Related Questions

BD Customer Advocacy

Phone: 888-812-3266

Phone hours: 7:00am to 5:00pm PT Monday – Friday

Email: customerfeedback@bd.comProduct Complaints

BD Technical Support

Phone: 888-812-3229

Phone hours: 6:00 am to 5:00 pm PT, Monday – Friday

Email: DL-US-INF-TechSupport@bd.com Technical Questions on the Alaris System

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US Med-Equip Mission

Our Mission is to promote the healing process by providing smart solutions for our partners and the patients they serve.

We are committed to your patients as much as you are — it’s rooted in our daily actions — so we understand the importance of safely servicing recalls promptly.

We have identified all the affected equipment pieces in our inventory and tracked them down for a product maintenance swap out. Last week at our National Support Center, a BD team completed servicing modules that they deem as Priority 1 Pumps, but all items with faulty bezels will be replaced. Once inspected, renewed, and tested, our Biomed team conducted final inspections and have classified them patient ready.

For any further questions regarding equipment recalls, please reach out to qa@usmedequip.com.