Alaris Pump Infusion Set Drip Chamber May Detach During Use
A defective drip chamber in the Alaris Pump Infusion Set may detach from the tubing, potentially delaying treatment or causing unintended exposure to medications. BD is recalling approximately 11,300 units distributed across the US and Canada.
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 defective medical device with potential to cause treatment delays or medication exposure. No illnesses or injuries have been reported. The FDA classified this as Class II, and the hazard is theoretical rather than realized, meeting the criterion for a High severity rating of a risk-of-harm product without reported injury.
Plain-English summary
BD SWITZERLAND SARL is recalling the Alaris Pump Infusion Set Low Sorbing Tubing with Back Check Valve 2 SmartSite Y Sites (Catalog Number 10013072, Lot Number 22115368). This tubing set is used to deliver fluids, medications, blood, and blood products in clinical settings.
The drip chamber of the tubing may detach from the tubing during use. A detached drip chamber can cause delays in treatment or expose users to the infusate being administered.
Approximately 11,300 sets were distributed nationwide in the states of Arkansas, California, Colorado, Illinois, Kansas, Massachusetts, Maine, New Jersey, New York, Pennsylvania, South Dakota, Washington, and Wisconsin, as well as in Canada. This is a Class II recall.
The recalled product
- Product
- Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
- Manufacturer
- BD SWITZERLAND SARL
- Hazard
- drip-chamber-detachment
- treatment-delay
- medication-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368
Distribution
Distributed nationwide across the United States.
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