Z-0449-2021 Class II Ongoing
FDA device recall Z-0449-2021 was initiated by Thomas Scientific on July 14, 2020 and is designated Class II. Reason for recall: The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval. The recall status is ongoing. Affected quantity: 115,800 cs (100 vials/cs).
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- July 14, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115,800 cs (100 vials/cs)
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.
Distribution Pattern
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.
Code Information
Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01