Smiths Medical ASD, Inc. 2025-05-14 Health critical FDA
Health · FDA · Recall #FDA-Z-1667-2025
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO… Recall
Issued May 14, 2025 · Smiths Medical ASD, Inc.
In May 2025, Smiths Medical ASD, Inc. recalled the CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Smiths Medical ASD, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Smiths Medical ASD, Inc.
- Category
- Health
- Recall date
- May 14, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US nationwide distribution.
- Recall number
- FDA-Z-1667-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Smiths Medical ASD, Inc. has 3 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.