Flocare Infinity Enteral Feeding Pumps
Published 25 August 2016
Product
Flocare Infinity enteral feeding pumps are used to supply nutrition to patients through tubes that lead directly into the stomach or intestine. Identifying features description Affected product codes: 35679, 35680 ARTG number: 119667
Why it was recalled
Nutricia Australia has received overseas reports of the Flocare Infinity enteral feeding pump 'air in line' (AIL) alarm not always working when used with mixed or reconstituted powdered tube feeds. It is believed that undissolved particles can accumulate in the feeding line or form a film on the inner side of the tube around the pump sensors, which can interfere with the pump's air detection function.
Hazard
If this occurs, it may result in the delivery of excess air into the patient's stomach with resulting discomfort and/or vomiting. If the AIL alarm was being used as an indicator that the reservoir was empty (i.e. feeding was completed), follow-up therapy might be delayed. This delay could place critical care and volume-sensitive patients at risk.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.