FDA recall Z-0449-2021

Thomas Scientific · Class II · device

Product

Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

Reason for recall

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Key facts

Status
Ongoing
Initiation date
2020-07-14
Report date
2020-11-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Swedesboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0449-2021