Smiths Medical CADD Administration Set Recalled for Incorrect Filter Size Illustration
Smiths Medical is recalling CADD Administration Sets because the illustration on the Instructions for Use incorrectly depicts the filter size as 2.0 microns instead of the actual 0.2 microns.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to a documentation and illustration error on the Instructions for Use. The source text does not report any illnesses, injuries, or adverse health consequences, and the actual product specification (0.2 micron filter) is correctly stated in the text, making this a low-risk labeling issue.
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD Administration Sets, part number 21-7339-24, due to a labeling error on the Instructions for Use (IFU). The text description on the IFU correctly identifies the product as containing a 0.2 micron filter, but the accompanying illustration incorrectly depicts the filter size as 2.0 microns.
The recall involves 38,415 units distributed across 46 U.S. states and Canada. The affected products are sterile, prescription-only administration sets used for medical purposes.
No specific instructions for consumer action are provided in the source text beyond the identification of the labeling discrepancy. Users should verify the filter size against the text description on the IFU, which accurately states the 0.2 micron specification.
The recalled product
- Product
- CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
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)
- 46X817
- 46X829
- 46X899
- 46X828
- 46X896
- 46X990
- 46X831
- 46X897
- 46X1001.
Distribution
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