Reported Oct 30, 2019 · Terminated
Irrisept Wound Debridement and Cleansing System. 12 units per case.
IrriMAX Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IrriMAX Corporation · 1665 Lakes Pkwy · Lawrenceville, GA · 30043-5881
Is this the product you have?
- Irrisept Wound Debridement and Cleansing System. 12 units per case.
- Lot codes and dates
- Catalog NumberISEPT-450-USA
- Lot Numbers
19CAB93919DAB431
- Expiration Date2021-04-30
- Amount recalled
- 1,031 cases (12,372 units)
Where it was sold
Why it was recalled
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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