Z-2247-2020 Class II Terminated
FDA device recall Z-2247-2020 was initiated by Radiometer Medical ApS on March 17, 2020 and is designated Class II. Reason for recall: The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. The recall status is terminated (terminated July 28, 2022). Affected quantity: 1314 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- March 17, 2020
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1314 units
Product Description
Reason for Recall
Distribution Pattern
U.S.: AK, AL, AR, CA, CO, CT, FL,GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI. OUS: Australia (New Zealand), Austria, Brazil Canada, China, Czech Republic (Slovakia), Denmark, Dubai (United Arab Emirates), Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Italy, Japan, Kazakhstan, Lithuania, Malawi, Malaysia, Mauritius, Netherlands (Belgium), Nicaragua, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Turkey (Cyprus), and United Kingdom.