BD Alaris Pump Infusion Sets may deliver medication outside safe parameters
BD Alaris Pump Infusion Sets may operate outside established performance ranges for flow rate and bolus accuracy, potentially delivering incorrect medication doses. Patients and healthcare providers should contact CareFusion.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric's rules. The hazard involves deviations from established performance parameters in a critical medication delivery device. No deaths, hospitalizations, or reported injuries are documented in the source.
Plain-English summary
CareFusion 303, Inc. is recalling BD Alaris Pump Infusion Sets because the infusion pump module may perform outside established performance ranges. Approximately 33,162,680 units are affected by this recall.
The sets may not maintain established performance ranges for flow rate accuracy, bolus accuracy, occlusion detection timing, and post-occlusion bolus volume. These infusion sets are used with compatible pumps to deliver medications. When the pump operates outside these ranges, patients may receive incorrect medication doses or experience delayed detection of delivery line blockages.
The affected sets have been distributed nationwide across the United States and internationally to Japan, Italy, Germany, and Turkey.
The recalled product
- Product
- BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pum
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- flow-rate
- bolus-accuracy
- occlusion-detection
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 (15)
- REF: 10013186/ UDI: 07613203021173
- REF: 2452-0007/ UDI: 10885403219870
- REF: 2204-0007/ UDI: 10885403199363
- REF: 24001-0007/ UDI: 10885403238666
- REF: 10015012/ UDI: 10885403233951
- REF: 2432-0007/ UDI: 10885403232329
- REF: 2434-0007/ UDI: 07613203019682
- REF: 2202-0007/ UDI: 10885403274039
- REF: 11426965/ UDI: 10885403232558
- REF: 10561554/ UDI: 10885403232565
- REF: 10863358/ UDI: 10885403232466
- REF: 11171447/ UDI: 07613203021234
- REF: 11532269/ UDI: 10885403232343
- REF: 10010454/ UDI: 07613203015806
- REF: 2465-0007/ UDI: 10885403221941
Distribution
Distributed nationwide across the United States.
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