Recall Z-1115-2022 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Radiometer Medical ApS
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
| Date | Apr 8, 2022 |
| Status | Open, Classified |
| Reason | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. |
| Root cause | Package design/selection |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962158 | PICO MODELS 30, 50, 70 Radiometer America, Inc., Oct 29, 1996 |