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U.S. Department of Health and Human Services

Class 3 Device Recall FloPatch

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 Class 3 Device Recall FloPatchsee related information
Date Initiated by FirmAugust 07, 2025
Date PostedSeptember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2517-2025
Recall Event ID 97427
510(K)NumberK200337 K223843 
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
ProductFloPatch FP120, REF: FP120-FOT01-005
Code Information UDI-DI: 10627987360148. Lot: 03250602
Recalling Firm/
Manufacturer		 Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Fourth Floor, Oneeleven
325 Front St W
Toronto Canada
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 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: cchin@flosonicsmedical.com
Quantity in Commerce9
DistributionUS Nationwide distribution in the state of California.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DPW
510(K)s with Product Code = DPW
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