FDA recall Z-0191-2020

Product

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

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2019-08-16

Report date

2019-10-30

Termination date

2020-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrenceville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0191-2020