Device product
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Z-2375-2024
Product summary
- Event
- Event 94817
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,008,000pcs (840 cartons)
- Official record key
device-enforcement:Z-2375-2024
Official wording
Reason: The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
Code information: Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV
Distribution pattern: Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV and WY.
Derived failure modes
-
Unknown
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.