Smiths Medical Recalls CADD High Volume Administration Sets Due to Incorrect Instructions
Smiths Medical is recalling 7,035 CADD High Volume Administration Sets because they contained the wrong instruction manual insert.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling/documentation error (incorrect IFU insert) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Smiths Medical ASD Inc. is recalling 7,035 units of the CADD High Volume Administration Set with FlowStop, part number 21-7381-24, lot number 26X035. The recall was initiated because the product incorrectly contained the instruction for use (IFU) insert intended for a different part number, 21-7357-24.
The affected products were distributed nationwide in Pennsylvania, Tennessee, Nevada, California, Maryland, Arkansas, Virginia, Ohio, Minnesota, New York, and Vermont. The CADD High Volume Administration Set is designed for use with the CADD Prizm pump to allow fluid delivery from an IV bag.
Consumers and healthcare providers should stop using the affected sets and contact Smiths Medical ASD Inc. for further instructions or a replacement.
The recalled product
- Product
- CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 7,035
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 (1)
- Lot#:26X035
Distribution
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