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Recall Observatory FDA recall evidence

Device product

FloPatch FP120, REF: FP120-FOT01-005

Z-2517-2025

August 07, 2025

Class III

Product summary

Firm
Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Event
Event 97427
Status
Ongoing
Classification
Class III
Quantity
9
Official record key
device-enforcement:Z-2517-2025

Official wording

Reason: Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

Code information: UDI-DI: 10627987360148. Lot: 03250602

Distribution pattern: US Nationwide distribution in the state of California.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.