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
Check against the official notice below — it lists the full affected range.
Radiometer Medical ApS is recalling Radiometer arterial blood samplers (REF 956-552, PIC050) containing 1 x 2 mL of 80 IU electrolyte-balanced heparin because sterility cannot be guaranteed throughout the product's shelf life. The affected product was distributed worldwide and in multiple U.S. states and countries, with approximately 7,228 boxes (100 units per box) recalled across all lots.
The recall notice does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Reason for recall: Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. 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, Lith Quantity: 7,228 boxes (100 units per box) Lot/code info: "All Lots" UDI/DI: 05700699565525
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.