Flocare Infinity Enteral Feeding Pumps

Official notice

25 Aug 2016

Last checked

25 Aug 2016

High riskACCC

An official ACCC notice concerns Flocare Infinity Enteral Feeding Pumps. 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. Published 2016-08-25.

What to do now

If you or somebody you provide care for uses a Flocare Infinity pump please be alert to the issue. If you use mixed or reconstituted powdered nutrition, Nutricia Australia recommends the following: •The 'dose' setting should be used and programmed, rather than relying on the AIL signal alone. When the required volume or dose has been delivered, an 'end of dose' message will appear on the screen and the pump will beep, after which the carer can take action. Do not mute the audio alarm indicating 'end of dose' in these instances. ◦When programming the 'dose' setting, the AIL alarm will remain functional. ◦Ensure that the volume of nutrition in the container is greater than the volume that is actually needed (i.e. More than the set dose) to prevent excessive air bubbles in the feeding line. •Ensure the mixed or reconstituted powdered nutrition is prepared and dissolved properly to avoid particles accumulating in the feeding set, potentially hampering pump performance and a normal feeding regimen. Nutricia Australia recommends that, where possible, patients use ready-made liquid tube nutrition, as this is developed for the delivery specifications of the pump. If you have any further questions or concerns, contact your health professional or Nutricia Australia on 1800 060 051 or email nccl@nutricia.com.

Recall number

c9d9172d-985d-4bdc-8500-95935b97fea0

Official notice

2016-08-25

The 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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Models

DESCRIPTION AFFECTED PRODUCT CODES

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Affected products

Product 1

Flocare Infinity enteral feeding pumps are used to supply nutrition to patients through tubes that lead directly into the stomach or intestine.

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

c9d9172d-985d-4bdc-8500-95935b97fea0

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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