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

Irrisept Wound Debridement and Cleansing System. 12 units per case. — recall Z-0191-2020

U.S. FDA — Device Enforcement · United States · 2019-08-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0191-2020
Date of alert
2019-08-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
IrriMAX Corporation
Product category
device
Product type
Devices
Reported risk: Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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