FDA Enforcement
Class II
Ongoing
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Recall: Z-2375-2024
·
Reported July 24, 2024
Enforcement
- Recall Number
- Z-2375-2024
- Event ID
- 94817
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Greiner Bio-One North America, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 24, 2024
- Initiation Date
- May 14, 2024
- Classification Date
- July 17, 2024
- Address
- 4238 Capital Dr, Monroe, NC, 28110-7681, United States
Description
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
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 Info
Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV
Distribution
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.
Quantity
1,008,000pcs (840 cartons)