Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0222-2025 — 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, 21-2101-0200-17, 21-2101-0

U.S. FDA — Device Enforcement · United States · 2024-07-16 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0222-2025
Date of alert: 2024-07-16
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Smiths Medical ASD Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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