The Recall Desk
HighFDA (Devices)·Z-1770-2019·Announced 2019-07-17

Becton Dickinson Recalls Alaris Pump Infusion Sets Due to Occlusion Defect

Becton Dickinson is recalling Alaris Pump Infusion Sets because a wall thickness variation can cause incomplete occlusion, potentially leading to unintended or faster-than-expected medication delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of unintended or accelerated medication delivery, which is a risk-of-harm product where injury has not yet been reported in the source text.

Plain-English summary

Becton Dickinson & Company is recalling Alaris Pump Infusion Sets due to a defect in the pumping segment. The recall involves 17,992 lots totaling 183,572,651 units, which were distributed worldwide, including nationwide in the United States and in several other countries.

The recall is being issued because a variation in the wall thickness of the pumping segment can cause an incomplete occlusion. This issue has the potential to lead to the unintended delivery of medication when the pump module is not in a running status, or it can result in faster-than-expected drug delivery flow when the pump is infusing.

Healthcare facilities and consumers should check their inventory for the specific model codes and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by Becton Dickinson & Company.

The recalled product

Product
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007,

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically: