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BD Provides Update On Voluntary Recall Of Alaris Pump Modules And Infusion Sets

Becton, Dickinson and Co. or BD (BDX) on Thursday provided an update on two voluntary recalls related to certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017, as well as certain model codes and lot numbers of the Alaris Pump Infusion Sets used with the Alaris Pump Model 8100.

BD said it has already notified customers affected by these recalls. Both products were formerly marketed under the CareFusion brand, which BD acquired in March 2015.

The FDA designated both actions as a Class I recall. Both recalls were associated with medical device reporting or MDR submissions, several of which are associated with serious injuries.

However, products manufactured after June 2017 are not affected by this recall, including the BD Alaris PCU and BD Alaris Pump Module that were introduced in March 2018.

BD said it is contacting the customers affected by the Alaris Pump Module Model 8100 bezel recall to schedule replacement of bezel assemblies.

In its April recall notification, BD had instructed customers to inspect all pumps included in this action during the annual preventive maintenance. If any damage was found, the pump should be removed from service and BD should be contacted.

However, BD said its revised recall notification indicated that until the bezels affected by this recall are replaced, customers should inspect both Priority 1 and Priority 2 pumps as soon as feasible.

In its recall notification sent on May 16, BD confirmed that an incomplete occlusion can occur on the pumping segment of certain Alaris Pump Model 8100 infusion sets due to a variation in the wall thickness of the pumping segment of the affected infusion sets.

Use of the affected products could lead to unintended delivery of medication when the pump module is not in running status, flow inaccuracies through the pumping cycle process resulting in an over-infusion, and the potential for serious patient injury depending on the type of medication that is being delivered.

BD has instructed customers to destroy all Alaris Infusion Sets affected by this recall.

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