CADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
Smiths Medical is recalling CADD Solis VIP Ambulatory Infusion Pumps due to potential thermal damage. The recall affects 313,676 units distributed nationwide and worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I. Per the severity rubric, FDA Class I recalls that are not Class I due to known fatalities are scored as Severe (4), unless other criteria elevate them to Critical (5).
Plain-English summary
Smiths Medical ASD, Inc. is recalling CADD Solis VIP Ambulatory Infusion Pump models (15 model numbers across multiple configurations) because of a potential for thermal damage in the devices.
The affected pumps were distributed nationwide and worldwide, with 313,676 items recalled. All serial numbers of the affected models are included in this recall.
Patients and healthcare providers should contact Smiths Medical ASD, Inc. for instructions on how to proceed with the recalled pumps. The FDA classified this recall as Class I due to the potential safety risk posed by thermal damage in infusion pumps used to deliver critical medications.
The recalled product
- Product
- CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KI
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 313,676
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)
- All serial numbers. 1 ) 21-2127-0105-01
- UDI-DI: 15019517150292
- 2 ) 21-2120-0105-01
- UDI-DI: 15019517150001
- 3 ) 21-2120-0103-01
- UDI-DI: 15019517084368
- 4 ) 21-2120-0102-51
- UDI-DI: 10610586042829
- 5 ) 21-2120-0104-01
- UDI-DI: 15019517126587
- 6 ) 21-2120-0103-51
- UDI-DI: 15019517096378
- 7 ) 21-2127-0104-01
- UDI-DI: 15019517126600
- 8 ) 21-2120-0105-00
- UDI-DI: 15019517149999
- 9 ) 21-2120-0103-78
- UDI-DI: 15019517096392
- 10 ) 21-2120-0102-78
- UDI-DI: 10610586042836
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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