Irrisept Wound Debridement and Cleansing System. 12 recall: Sterility Concern
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Why was Irrisept Wound Debridement and Cleansing System. 12 recalled?
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30
- Product
- Irrisept Wound Debridement and Cleansing System. 12 units per case.
- Recalling firm
- IrriMAX Corporation
- Quantity
- 1,031 cases (12,372 units)
- Distribution
- Nationwide distribution to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.
- Recall date
- October 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)