Cardinal Health Recalls Enteral Infusion Pumps Due to Air Risk
Cardinal Health is recalling 146,944,334 Enteral Infusion Pumps because air may appear in the tubing during set-up.
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 3/5 (High).
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 146,944,334 units of Enteral Infusion Pumps. The recall is due to a potential for air to appear in the enteral feed pumping set tubing during set-up.
The affected products are identified by catalog numbers 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, and 776150. These products were distributed domestically in all 50 states and DC, and internationally in Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, and Turkey.
The FDA has classified this recall as Class II. Consumers and healthcare providers should check their devices for the listed catalog numbers and contact Cardinal Health for further instructions.
The recalled product
- Product
- Enteral Infusion Pump
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 146,944,334
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 (20)
- Catalog Number: 612054
- 613650
- 614650
- 672055
- 673656
- 673662
- 674655
- 674668
- 674669
- 716154
- 762055
- 763656
- 763662
- 765100
- 765559
- 772055
- 773656
- 773662
- 775100
- 775659
Distribution
Distribution scope not specified by the agency.
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