Z-2128-2024 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
- 0
Product Description
Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-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
Lot Code: LOT: N/A