Recall Z-0449-2021— Thomas Scientific
Class II · Ongoing
Class II FDA medical device recall by Thomas Scientific, initiated 2020-07-14. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Thomas Scientific
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-07-14
- Firm location
- Swedesboro, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.