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Recall Observatory FDA recall evidence

Device product

Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE

Z-1115-2022

April 08, 2022

Class II

Product summary

Firm
Radiometer Medical ApS
Event
Event 90093
Status
Ongoing
Classification
Class II
Quantity
7,228 boxes (100 units per box)
Official record key
device-enforcement:Z-1115-2022

Official wording

Reason: Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.

Code information: "All Lots" UDI/DI: 05700699565525

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DC, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, TN, TX, WA, WI and the countries of Canada, Italy, Norway, Austria, Algeria, Argentina, Bolivia, Bosnia, Brazil, Burkina, Faso, Chile, Colombia, Cyprus, Ecuador, Egypt, Eswatin, Ethiopia, Greece, Guatemala, Israel, Lebanon, Libya, Lithuania, Malawi, Nicaragua, Romania, Senegal, Serbia, Slovenia, Thailand, Uganda, Uruguay, Vietnam, Zimbabwe, Belgium, Netherlands, China, Macao, Croatia, Hungary, Denmark, Iceland, Germany, Spain, Portugal, India, Japan, United Kingdom, Ireland, Russia, Australia, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Georgia, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility cannot be guaranteed