medical Class II Updated 2019-10-30

IrriMAX Corporation recalls Irrisept Wound Debridement and Cleansing System. 12 units pe

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30
View official government recall

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