CADD-Solis VIP Ambulatory Infusion Pump Class I Recall
Smiths Medical is recalling CADD-Solis VIP Model 2110 infusion pumps in a Class I action affecting units worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. Per the severity rubric, FDA Class I recalls score at minimum 4 (Severe). No reported deaths appear in the provided source, so the classification does not reach 5 (Critical).
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD-Solis VIP Model 2110 ambulatory infusion pumps in a Class I action. A Class I recall is the most serious FDA classification, indicating a reasonable probability that use of the affected device could cause serious adverse health consequences or death.
The CADD-Solis VIP is designed for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion of medications and therapies requiring continuous rates, intermittent boluses, or patient-controlled demand doses. The recall affects multiple units identified by specific serial numbers and distributed worldwide.
Patients currently using affected pumps and healthcare providers should contact Smiths Medical for instructions regarding corrective action.
The recalled product
- Product
- CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- 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 (20)
- REF List Number 21-2111-0100-00
- UDI/DI 10610586039195
- Serial Numbers: 10610586039195
- REF List Number 21-2111-0100-51
- UDI/DI 30610586039205
- Serial Numbers: 1008871
- 1011314
- 1011695
- 1012140
- 1012157
- 1012387
- 1012393
- 1012430
- 1012607
- 1012611
- 1012749
- 1012751
- 1012752
- 1012758
- 1012765
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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