CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smiths Medical ASD Inc.
- Reason for Recall:
- Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Product Codes/Lot Numbers:
46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1767-2017
Related Recalls
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Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
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