Recall Z-0191-2020 ยท FQH Lavage, Jet
IrriMAX Corporation
Irrisept Wound Debridement and Cleansing System. 12 units per case.
| Date | Aug 16, 2019 |
| Status | Terminated |
| Reason | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. |
| Root cause | Process control |
| Action | Irrimax Corporation notified customers on about 08/16/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter informed customers that the recall was due to the potential of a defect in the sterile pouch seal, which may result in a lack of sterility assurance, and that the seal defect is not easily visible upon inspection of the pouch. Instructions to customers included, that within 10 business days of receiving the recall notification, they are to discontinue use of the recalled product (labeled lot numbers 19CAB939 or 19DAB431), complete and return the attached Recall Return Response |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM Irrimax Corporation, Feb 4, 2009 |