Technical summary for bezel post separation recall

BD has conducted an extensive investigation leveraging engineering and scientific capabilities from within BD as well as external experts. The component of the Alaris Pump module for this recall is the bezel assembly (Figure 1)  and the issue involves separation of the bezel posts (Figure 2). The bezel has six posts that connect the pumping mechanism frame to the bezel assembly and are critical to proper performance of the pump.

Investigation of the issue

BD’s ongoing investigation has determined that the bezel manufacturing process may have resulted in weakened plastic. Over time, the plastic may lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking).

Our investigation identified certain months of bezel manufacturing that exhibited weakened plastic through a test known as the Melt Flow Rate, or MFR. The higher the MFR, the more the plastic material has been weakened during the manufacturing process. BD collected bezels to assess MFR and conducted testing and analyses to determine the bezels with the weakest plastic. These bezels will be prioritized for remediation first. The remaining bezels have lower risk.

BD also conducted accelerated life testing on bezels in the higher risk group, lower risk group, and on bezels manufactured from the new Valox material that was introduced in 2017.

Here are some important facts from the testing:

  • None of the bezels from the lower risk months exhibited any cracking or separation throughout seven years of accelerated life testing
  • None of the bezels manufactured after June 2017 with the new Valox material exhibited any cracking or separation throughout 10 years of accelerated life testing
  • Bezels from the higher risk months exhibited cracking as early as the first year of life testing, but no separations were observed until year four

Affected products

BD is committed to minimizing disruption to patient care during this process. Affected pumps have different levels of risk. BD is prioritizing remediation efforts based on risk into two major groups:  Priority 1 and  Priority 2.

Priority 1

Alaris Pump Module 8100 manufactured between April 2011 and October 2014, inclusive

  • There are 14 injuries reported to date within Priority 1.
  • BD will replace all Priority 1 bezels first. BD is targeting replacement of all Priority 1 bezels within 12 months.

Non-affected products

Beginning in June 2017, BD began making bezels with a different plastic material called Valox. Valox bezels have been tested extensively by BD. There have been no patient injuries or complaints of cracking associated with Valox bezels to date.

The recall DOES NOT affect the following

Priority 2

Alaris Pump Module 8100 manufactured between November 2014 and June 2017, inclusive

  • To date, there have been no reported patient injuries associated with Priority 2 pumps.
  • BD will replace Priority 2 bezels within 24 months.
  • Note:  Priority 2 pumps have a reduced likelihood of weakened plastic leading to cracked bezel issues compared to the Priority 1 pumps.

Non-affected products

Beginning in June 2017, BD began making bezels with a different plastic material called Valox. Valox bezels have been tested extensively by BD. There have been no patient injuries or complaints of cracking associated with Valox bezels to date.

The recall DOES NOT affect the following

Affected spare parts

In addition to these pumps, the following replacement parts that contain bezel assemblies made with the affected plastic are recalled:

Non-affected products

Beginning in June 2017, BD began making bezels with a different plastic material called Valox. Valox bezels have been tested extensively by BD. There have been no patient injuries or complaints of cracking associated with Valox bezels to date.

The recall DOES NOT affect the following


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