Open, Classified

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

FDA Recall Z-1115-2022 · Posted None

Recalling FirmRadiometer Medical ApS

Recall StatusOpen, Classified

Product CodeJKA

Date Initiated2022-04-08

Product Quantity7,228 boxes (100 units per box)

Reason for Recall

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

Firm Action

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 @ [email protected] to receive a Return Goods Authorization

Root Cause

Package design/selection

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962158PICO MODELS 30, 50, 70Radiometer America, Inc. · 1996-10-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.