Z-1683-2021 Class II Terminated
FDA device recall Z-1683-2021 was initiated by Radiometer Medical ApS on March 26, 2021 and is designated Class II. 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 Sam… The recall status is terminated (terminated March 1, 2023). Affected quantity: 348,178 boxes worldwide (1,883 boxes in the U.S.).
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
Reason for Recall
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.