FDA Medical Device Recalls (openFDA)
Thomas Scientific: Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
- Recall number
- Z-0449-2021
- Recalling firm
- Thomas Scientific
- Product
- Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
- Status
- Open, Classified
- Initiated
- 2020-07-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIO
- Firm FEI
- 2522600
- Firm city
- Swedesboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28