FDA-Device2020-11-25Class II
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Thomas Scientific
Hazard
The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
Sold states
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.
Affected count
115,800 cs (100 vials/cs)
Manufactured in
1654 High Hill Rd, N/A, Swedesboro, NJ, United States
Products
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0449-2021Don't want to check this manually?
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