Z-1683-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- March 26, 2021
- Termination Date
- March 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 348,178 boxes worldwide (1,883 boxes in the U.S.)
Product Description
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; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;
Reason for Recall
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 the sterile barrier system for the Arterial Blood Sampler.
Distribution Pattern
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, Lebanon, Lithuania, Malawi, Mali, Oman, Peru, Romania, Saudi Arabia, Senegal, Uganda, United Arab Emirates, Austria, Belgium, Netherlands, Luxembourg, China, Taiwan, Croatia, Czech Republic, Slovakia, Denmark, Faroe Islands, Iceland, Finland, France, Germany, Hungary, India, Maldives, Italy, Japan, Kazakhstan, Mexico, Norway, Poland, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, Georgia, and United Kingdom.
Code Information
Model Numbers: PICO70, Arterial blood sampler without needle: 956-518; 956-519; PICO70, Arterial blood sampler with needle: 956-522; 956-525; 956-529; 956-533; 956-534; 956-547;