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embecta Medical II LLC: EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100

Medical DevicesSource: FDA (device) · Date: 2026-09-23

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
embecta Medical II LLC
Product
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Reason / hazard
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.
Recall initiated
2023-07-26
Code info
No UDI/All products labeled "for Investigational Use Only"
Product quantity
4300 Final Count (in EA)
Voluntary mandated
Voluntary: Firm initiated
City
Parsippany
State
NJ
Country
United States
Event id
99593
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