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
- Recall Initiated
- April 8, 2022
- Recall Number
- Z-1115-2022
- Quantity
- 7,228 boxes (100 units per box)
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, 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.
Lot / Code Info
"All Lots" UDI/DI: 05700699565525
Root Cause
Package design/selection
Action Taken
On April 26, 2022 Radiometer issued a "Urgent Medical Device Recall" notification via Email. The firm ask consignees to take the following actions: Radiometer kindly request you to stop using the affected product with immediate effect. To ensure patient safety in your facility, kindly follow the steps below: " Check your inventory of the above PICO50 Arterial Blood Samplers " Check for the above PICO50 Arterial Blood Samplers distributed in your institution. " Collect any of the above PICO50 Arterial Blood Samplers and put on quarantine " Complete the Recall Response Form (last page of this letter) and return to your Radiometer representative together with the quarantined PICO50 Arterial Blood Samplers. To ensure you receive credit for the PICO50 Arterial Blood Samplers, please contact Customer Service @ CSRsupport@radiometeramerica.com to receive a Return Goods Authorization