CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S

FDA device recall Z-0222-2025 · posted 2024-10-31 · Open, Classified

Recall details

Recalling firm

Smiths Medical ASD Inc.

Reason for recall

Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.

Action taken

Smiths Medical issued an URGENT MEIDCAL DEVICE CORRECTION to its consignees on 07/16/2024 via traceable mailing. The notice explained the issue, potential risk and requested the following actions be taken: 1. Examine the external condition of the battery pack and look for evidence of damage to the outer case. As stated in the battery pack Instructions for Use, if the battery pack housing is cracked or otherwise damaged, replace the battery pack. NEVER use a battery pack that appears damaged. A rechargeable battery pack must be replaced with either another CADD-Solis rechargeable battery pack or with 4 AA batteries. 2. Users with damaged battery packs should submit complaints to: globalcomplaints@icumed.com; 1-866-216-8806 3. Ensure all users or potential users of these products are immediately made aware of this notification. 4. Complete and return response form to smithsmedical5437@sedgwick.com. 5. 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 smithsmedical5437@sedgwick.com

Root cause

Component design/selection

Status

Open, Classified

Product code

FRN

Quantity affected

138039 units

Distribution

Worldwide Distribution

Date initiated

2024-07-16

Date posted

2024-10-31

Location

Minneapolis, MN

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