Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
- Company
- Thomas Scientific
- Recall Initiated
- July 14, 2020
- Recall Number
- Z-0449-2021
- Quantity
- 115,800 cs (100 vials/cs)
- Firm Location
- Swedesboro, NJ
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.
Lot / Code Info
Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01
Root Cause
No Marketing Application
Action Taken
On 8/31/20, the firm provided FEMA with the recall letter, which was distributed to all affected users. Users were informed that product manufactured and distributed prior to Enforcement Discretion Approval was to be removed. The firm offered to replace any returned product. To report and receive replacement, customers should complete the included VTM Product Replacement Form and return it to QC@ThomasSci.com. Thomas Scientific will replace any product that has been returned. Please contact QC@ThomasSci.com for any requests for field support.