The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0449-2021·Announced 2020-11-25

Thomas Scientific Recalls Wuxi Nest Patient Specimen Collection Tubes

Thomas Scientific is recalling Wuxi Nest patient specimen collection tubes to replace units manufactured and distributed prior to Enforcement Discretion Approval.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, placing it in the High severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Thomas Scientific is recalling Wuxi Nest patient specimen collection tubes, including model numbers 202115, 202117, 202017, and 202018. The recall involves 115,800 cases, with each case containing 100 vials. The affected lots include 060620MB1, 061420MB2, 062120MB1, 062220MB2, 060620MB2, 052220MB1, 051820D01, 060120D01, 061520MA1, 062220D02, 061720MB1, 052720D02, 061920E01, and 052120E01.

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval. The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed nationwide, 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, and WY.

Healthcare facilities and consumers who have these specific model numbers and lot codes should stop using the affected tubes and contact Thomas Scientific for a replacement.

The recalled product

Product
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Manufacturer
Thomas Scientific
Category
Medical Device — Specimen Collection
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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