CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, in
FDA device recall Z-2420-2024 · posted 2024-08-03 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
- Action taken
- Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/27/2024 via letter distributed using traceable means. The notice explained the issues affecting the devices, potential risks, and requested the following: "Required Actions for Users: 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to smithsmedical3563@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical3563@sedgwick.com Follow up Actions by Smiths Medical: Smiths Medical is sending this notification to all affected CADD-Solis customers and is addressing the issues described in this notice through software updates. Smiths Medical will contact you to schedule the implementation of the software updates." For questions contact: 1. Additional information or technical assistance: TSC.Support@icumed.com; 1-800-241-4002, option 3, 4 (M-F, 8:00 am 6:00 pm CT) 2. Questions about this Field Correction Notice: icumed.custhelp.com/app/market-action
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Open, Classified
- Product code
- MEA
- Distribution
- Worldwide
- Date initiated
- 2024-02-27
- Date posted
- 2024-08-03
- Location
- Minneapolis, MN
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