FDAJuly 26, 2023
embecta Medical II LLC Pen Needles Recall Over Investigational Use Only Labeling
FDA published this notice on July 26, 2023 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- July 26, 2023
- Recall class
- Class II
- Reason given by the agency
- Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
- Distribution
- 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.
- Official source
- the notice at its source
Official warnings by state, with every type counted since 2008Search notices, places and declaration numbers
Source: FDA.