Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure
Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the failure of occlusion alarms in a medical device used for enteral feeding poses a significant risk of harm, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling 223 units of the Kangaroo Connect Enteral Feeding Pump (Item Number: 384400) due to a defect where occlusion alarms fail to alarm. The device is intended to provide enteral nutrition to patients in hospital and acute care settings. The recall is classified as Class II by the FDA.
The affected pumps were distributed worldwide, including in the USA, Australia, Canada, France, and Singapore. The specific serial numbers for the affected units are listed in the official recall documentation. No specific dates of distribution or manufacturing are provided in the source text.
Healthcare facilities and consumers should check their inventory for the affected serial numbers. If a unit is found, it should be removed from service and returned to Medtronic for repair or replacement according to the manufacturer's instructions. Users should monitor patients closely for signs of occlusion, as the alarm system may not function as intended.
The recalled product
- Product
- Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
- Manufacturer
- Medtronic
- Affected units
- 223
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic 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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