Radiometer Medical ApS Recall 90093
Description: 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
Radiometer Medical ApS Recall 90093 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1115-2022 |
| Event ID | 90093 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 7,228 boxes (100 units per box) |
| Recall Reason | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. |
| Device Classification | 20220525 |
| Device Code Info | "All Lots" UDI/DI: 05700699565525 |
| Center Classification Date | 20220519 |
| Recall Initiation Date | 20220408 |
| Recalling Firm | Radiometer Medical ApS |
| Initial Notification | |
| Similar To |