FloPatch FP120, REF: FP120-FOT01-005
FDA Recall Z-2517-2025 · Posted 2025-09-04
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Recalling FirmFlosonics Medical (R/A 1929803 ONTARIO CORP.)
Recall StatusOpen, Classified
Product CodeDPW
Date Initiated2025-08-07
Product Quantity9
Reason for Recall
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.
Firm Action
On 8/7/2025, recall notices were emailed to customers who were asked to do the following:
1. Customers to confirm receipt of recall notice.
2. Customers should dispose of the outer shipping packaging.
3. If desired, customers may request replacement product.
For questions, please contact: [email protected]
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the state of California.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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