Z-2100-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- April 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110000
Product Description
Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No
Reason for Recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
Code Information
UDI-DI code: 00853620005241 Lot Code: LOT: EJ117-5, EJ117-6, EJ117-7, EJ117-8, EJ117-9, EJ117-10, EJ117-11