Recall Z-0191-2020— IrriMAX Corporation

Name: FDA recall Z-0191-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-16

Class II · Terminated

Class II FDA medical device recall by IrriMAX Corporation, initiated 2019-08-16, terminated 2020-09-25. It names one FDA 510(k) clearance: K080779. Product: Irrisept Wound Debridement and Cleansing System. 12 units per case.. Reason: Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance..

Recalling firm: IrriMAX Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-08-16
Terminated: 2020-09-25
Firm location: Lawrenceville, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K080779 — IRRISEPT WOUND CLEANSING SYSTEMIrrimax Corporation·cleared 2009-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Irrisept Wound Debridement and Cleansing System. 12 units per case.

Reason for recall

Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.