Recall Z-1683-2021 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Radiometer Medical ApS
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm
| Date | Mar 26, 2021 |
| Status | Terminated |
| Reason | Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with |
| Root cause | Under Investigation by firm |
| Action | On 03/26/2021, the firm initially sent an "Urgent: Medical Device Recall" Notification Letter via email and followed up with a hardcopy via FedEx. The Notification Letter informed customers that the Recalling Firm had become aware of an issue related to the sterile barrier system for its arterial blood sampler product. The potential risks associated with the affected products could potentially be bacterial bloodstream infection with immunosuppressed patients being at particular risk. Customers are instructed to: 1) Check their inventory of the affected Arterial Blood Samplers 2) Check for t |
| Quantity | 348,178 boxes worldwide (1,883 boxes in the U.S.) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, IL, LA, MA, MI, MO, MT, NJ, NY, OK, PA, TX, WA, and WI. The countries of Australia, New Zealand, Canada, Algeria, Bahrain, Belarus, Bosnia and Herzegovina, Colombia, Costa Rica, Ethiopia, Greece, Guatemala, Indonesia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.