IrriMAX Recalls Irrisept Wound Debridement System Due to Seal Defect
IrriMAX Corporation is recalling 1,031 cases of Irrisept Wound Debridement and Cleansing Systems because a potential defect in the sterile pouch seal may result in a lack of sterility assurance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a lack of sterility assurance poses a risk of harm (infection), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
IrriMAX Corporation is voluntarily recalling 1,031 cases (12,372 units) of the Irrisept Wound Debridement and Cleansing System. The recall is due to a potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
The affected products are identified by Catalog Number ISEPT-450-USA and Lot Numbers 19CAB939 and 19DAB431, with an expiration date of April 30, 2021. The products were distributed nationwide to 34 states, including Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
Consumers and healthcare facilities should stop using the affected products and contact IrriMAX Corporation for further instructions or a refund.
The recalled product
- Product
- Irrisept Wound Debridement and Cleansing System. 12 units per case.
- Manufacturer
- IrriMAX Corporation
- Category
- Medical Device — Wound Care
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog Number: ISEPT-450-USA
- Lot Numbers: 19CAB939
- 19DAB431
- Expiration Date: 2021-04-30
Distribution
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