Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Reported: November 25, 2020 Initiated: July 14, 2020 #Z-0449-2021
Product Description
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.
Details
- Recalling Firm
- Thomas Scientific
- Units Affected
- 115,800 cs (100 vials/cs)
- 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.
- Location
- Swedesboro, NJ
Frequently Asked Questions
What product was recalled? ▼
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.. Recalled by Thomas Scientific. Units affected: 115,800 cs (100 vials/cs).
Why was this product recalled? ▼
The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0449-2021.
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