FDA recall Z-1916-2023

Product

Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Distribution

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

Key facts

Status

Ongoing

Initiation date

2023-04-22

Report date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1916-2023