Ambulatory Infusion System Batteries May Short Circuit and Overheat
CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 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: This FDA Class I recall requires a minimum severity of 4 per the rubric. While no illnesses or injuries have been reported, a potential short circuit and case melting in a battery pack powering an ambulatory infusion system—a critical medication delivery device—constitutes a serious hazard.
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD-Solis Li-ion rechargeable battery packs (REF 21-2160-XX) and their associated ambulatory infusion systems. The recall affects 138,039 units worldwide, with all serial numbers included.
Battery pack damage may cause a short circuit to a capacitor within the pack. The battery case is designed to be flame retardant; however, this short circuit could lead to melting of the battery pack case. If the case melts, the battery pack charging circuit may become inoperable.
The recall includes both standalone battery packs and these packs as components of multiple CADD-Solis Ambulatory Infusion System models manufactured by Smiths Medical ASD Inc.
The recalled product
- Product
- CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14…
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 138,039
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 (1)
- All serial numbers.
Distribution
Distribution scope not specified by the agency.
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