Smiths Medical CADD-Solis VIP Ambulatory Infusion Pumps Recalled Worldwide
Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.
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: FDA Class I classification requires a minimum severity score of 4 per the rubric. Class I recalls indicate potential for serious injury or death. Although specific illnesses or injuries are not documented in the provided source, the Class I designation combined with worldwide distribution and large number of affected units indicates a critical safety issue.
Plain-English summary
Smiths Medical ASD Inc. is recalling the CADD-Solis VIP ambulatory infusion pump, including models 21-2120, 21-2125, and 21-2127, distributed worldwide. These pumps are indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, and subarachnoid space infusion. They are designed to deliver continuous infusion rates, intermittent bolus doses, and patient-controlled demand infusions.
The FDA has assigned this a Class I recall classification. Affected units are identified by multiple reference list numbers (21-2120-0100-02, 21-2120-0100-03, 21-2120-0100-50, 21-2120-0102-02, 21-2120-0102-03, 21-2120-0102-06, 21-2120-0102-51, and 21-2120-0103-01) with corresponding Universal Device Identifiers and specific serial numbers.
Patients and healthcare providers using affected pumps should stop using them immediately and contact Smiths Medical ASD Inc. for instructions on device replacement or alternative infusion methods. To determine if a pump is affected, check the device's model number and serial number against the official FDA recall notice. Healthcare facilities should verify their inventory against the affected serial numbers.
The recalled product
- Product
- CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies t
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- device-malfunction
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 21-2120-0100-02
- UDI/DI 10610586040429
- Serial Numbers: 1033919
- REF List Number 21-2120-0100-03
- UDI/DI 30610586040430
- Serial Numbers: 1024307
- 1024333
- 1025299
- 1027869
- 1027794
- REF List Number 21-2120-0100-50
- UDI/DI 10610586038501
- Serial Numbers: 1015104
- 1032637
- 1019622
- 1019666
- 1019677
- 1019718
- 1019720
- 1019790
Distribution
Distribution scope not specified by the agency.
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