FDA Device recall Z-0449-2021
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection
- FDA Device
- Class II
- ongoing
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection by Thomas Scientific, citing the firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0449-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-14 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Thomas Scientific |
| Distribution | US |
Product
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Reason
The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
Identifiers
| code_info | Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 0622…Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0449-2021%22
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