FDA-Device2020-06-10Class II
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Radiometer Medical ApS
Hazard
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Sold states
U.S.: AK, AL, AR, CA, CO, CT, FL,GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI. OUS: Australia (New Zealand), Austria, Brazil Canada, China, Czech Republic (Slovakia), Denmark, Dubai (United Arab Emirates), Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Italy, Japan, Kazakhstan, Lithuania, Malawi, Malaysia, Mauritius, Netherlands (Belgium), Nicaragua, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Turkey (Cyprus), and United Kingdom.
Affected count
269 units
Manufactured in
Akandevej 21, N/A, Bronshoj, N/A, Denmark
Products
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2248-2020Don't want to check this manually?
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