CADD Administration Sets with Incorrect Air Filter Assembly
Smiths Medical is recalling CADD Administration Sets (Model #21-7346-24) distributed in Canada because the air filter may have been assembled incorrectly. This manufacturing defect could impact device function.
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: This FDA Class II medical device recall involves a manufacturing defect with no reported illnesses or injuries. The incorrect air filter assembly in an infusion administration set represents a risk-of-harm scenario, fitting the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD Administration Sets, Model #21-7346-24, distributed in Canada. The recall affects 371 units across nine lot numbers: 3750848, 3776357, 3793886, 3766764, 3793887, 3796141, 3776356, 3793888, and 3847669.
The product may have been manufactured with an air filter assembled in an incorrect orientation. This manufacturing defect could affect the device's ability to function as intended during medication infusion.
No illnesses or injuries associated with this defect have been reported. However, the incorrect assembly represents a functional risk for infusion administration.
Consumers and healthcare providers who have received this product should contact Smiths Medical ASD Inc. to determine appropriate corrective action based on their lot number.
The recalled product
- Product
- CADD Administration Sets, Model #21-7346-24
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 371
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 (9)
- Lot Numbers: 3750848
- 3776357
- 3793886
- 3766764
- 3793887
- 3796141
- 3776356
- 3793888
- 3847669
Distribution
Distribution scope not specified by the agency.
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