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Recall Observatory FDA recall evidence

Device product

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

Z-0466-2025

June 26, 2024

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 95483
Status
Ongoing
Classification
Class II
Quantity
156,400 AC adapters
Official record key
device-enforcement:Z-0466-2025

Official wording

Reason: The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

Code information: Model 21-0270-25, UDI/DI 15019517126844, All lots

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.