CareFusion Alaris PCA Pump Recall Due to Syringe Plunger Gripper Failure
CareFusion is recalling Alaris PCA Pumps because the syringe plunger grippers may fail to close automatically, potentially affecting 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 harm to patients by potentially disrupting medication delivery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
CareFusion 303, Inc. is recalling 73,611 units of the Alaris PCA Pump, Model 8120. These infusion pump modules are used to deliver medication or fluids to adults, pediatrics, and neonates through intravenous, subcutaneous, or epidural routes. The devices were manufactured or serviced between May 1, 2013, and April 30, 2017.
The recall is due to a defect where the syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. This failure could impact the intended delivery of medication or fluids.
The affected devices were distributed nationwide in the United States, including to government and military entities, as well as to foreign countries including Canada, the United Arab Emirates, Bahrain, Switzerland, the United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwan, and South Africa. Users should contact CareFusion for instructions on how to address the defect.
The recalled product
- Product
- Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pump
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 73,611
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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