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

Recall date

July 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0449-2021

FDA classification

Class II

Brand / firm

Thomas Scientific

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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