Last Edited Date: August 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.
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.
Update (July 31st, 2019)
Certain Alaris™ Pump Modules Model 8100 manufactured between April 2011 and June 2017 are being replaced by BD, urging customers and users to contact them for a replacement of bezel assemblies. An update mentions that there are no further changes to the affected product list. Customers should continue to refer to the attachments included in the recall notification issued on April 15, 2019.
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 hours: 7:00 am to 4:00 pm PT, Monday – Friday
Email: SupportCenter@bd.com: General Follow-up or Recall Related Questions
BD Customer Advocacy
Phone hours: 7:00am to 5:00pm PT Monday – Friday
Email: firstname.lastname@example.org: Product Complaints
BD Technical Support
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
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 email@example.com.