Smiths Medical CADD-Legacy 1 Pumps Recalled for Serial Number Mismatch
Smiths Medical ASD Inc. is recalling 58 CADD-Legacy 1 Ambulatory Infusion Pumps because the physical label may not match the serial number programmed into the device software.
What this means for you
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, but the specific defect is a documentation/labeling error (serial number mismatch) rather than a direct functional failure or contamination, aligning with the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Smiths Medical ASD Inc. is recalling 58 units of the CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump (REF 21-6400-51, PC 10008552-001). The recall is due to a labeling discrepancy where the serial number printed on the label attached to the back of the pump may not match the serial number programmed into the pump's software.
The affected units were distributed in the United States and Australia. The specific serial numbers involved range from 409963 to 410020. This issue is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check the serial number on the physical label against the serial number displayed in the pump's software. If a mismatch is found, the device should be stopped and the recalling firm, Smiths Medical ASD Inc., should be contacted for further instructions.
The recalled product
- Product
- CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 58
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)
- Serial Numbers: 409963
- 409964
- 409965
- 409966
- 409967
- 409968
- 409969
- 409970
- 409971
- 409972
- 409973
- 409974
- 409975
- 409976
- 409977
- 409978
- 409979
- 409980
- 409981
- 409982
Distribution
Distribution scope not specified by the agency.
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