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.
What this means for you
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
Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02