Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Wuxi Nest

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Wuxi Nest see related information
Date Initiated by Firm July 14, 2020
Create Date November 13, 2020
Recall Status1 Open3, Classified
Recall Number Z-0449-2021
Recall Event ID 86607
Product Classification Device, specimen collection - Product Code LIO
Product Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Code Information Lots  060620MB1  061420MB2  062120MB1  062220MB2  060620MB2  052220MB1  051820D01  060120D01  061520MA1  062220D02  061720MB1  052720D02  061920E01  052120E01 
Recalling Firm/
Manufacturer		 Thomas Scientific
1654 High Hill Rd
Swedesboro NJ 08085-1780
For Additional Information Contact Philip Wikoff
833-544-7447
Manufacturer Reason
for Recall		 The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
FDA Determined
Cause 2		 No Marketing Application
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-