Device product
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Z-2247-2020
Product summary
- Event
- Event 85478
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1314 units
- Official record key
device-enforcement:Z-2247-2020
Official wording
Reason: The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Code information: Lot numbers:R2425 - R2524
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.
Derived failure modes
-
Unknown
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.