Smiths Medical recalls certain CADD-Solis HPCA Ambulatory Infusion Pumps with model numbers 21-2111-0402-09-KYO and others due to false upstream occlusion alarms that can interrupt therapy, risking serious injury or death.
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.
Smiths Medical is recalling specific CADD-Solis HPCA Ambulatory Infusion Pumps that may trigger false alarms, which can interrupt medication delivery and lead to serious injury or death. Affected pumps have model numbers starting with 21-2111-0402-09-KYO and others listed in the recall notice.
The pumps may trigger a false 'upstream occlusion' alarm under certain conditions, causing the infusion to stop or slow. This interruption can lead to serious injury or death if the patient requires continuous medication delivery.
Patients using the recalled CADD-Solis HPCA Ambulatory Infusion Pumps for medication delivery are most at risk. Healthcare providers and caregivers who use these pumps for clinical evaluations or demos are also affected.
Check for model numbers starting with 21-2111-0402-09-KYO or other specific numbers listed in the recall notice. The pumps are used for clinical evaluations, demos, or loaner units in healthcare settings.
Look for model numbers starting with 21-2111-0402-09-KYO or other specific numbers listed in the recall notice.
If you have the pump, contact Smiths Medical directly for further instructions on the recall.
Model numbers starting with 21-2111-0402-09-KYO and others listed in the recall notice, including specific pump kits for clinical evaluations and demos.
The pump may trigger a false 'upstream occlusion' alarm, which can interrupt medication delivery and lead to serious injury or death.
No, but you should check the model number and contact Smiths Medical if you have the pump to get further instructions.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1667-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1667-2025 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
