FDA Devices Moderate Class II Ongoing

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

Reported: May 25, 2022 Initiated: April 8, 2022 #Z-1115-2022

Product Description

Reason for Recall

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

Details

Recalling Firm: Radiometer Medical ApS
Units Affected: 7,228 boxes (100 units per box)
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.
Location: Bronshoj, N/A

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Radiometer Medical ApS. Units affected: 7,228 boxes (100 units per box).

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1115-2022.