Z-2375-2024 Class II Ongoing
FDA device recall Z-2375-2024 was initiated by Greiner Bio-One North America, Inc. on May 14, 2024 and is designated Class II. Reason for recall: 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 reco… The recall status is ongoing. Affected quantity: 1,008,000pcs (840 cartons).
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- May 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,008,000pcs (840 cartons)
Product Description
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Reason for Recall
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.
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.
Code Information
Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV