Z-2109-2024 Class II Ongoing
FDA device recall Z-2109-2024 was initiated by Jiangsu Shenli Medical Production Co., Ltd. on April 5, 2024 and is designated Class II. Reason for recall: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). The recall status is ongoing. Affected quantity: 1248000.
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
- 1248000
Product Description
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M 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: SL21030101,SL21040101,SL21070101,SL21090101,SL21110101,SL21 110301,SL21120101,SL22030101, SL22070101,SL22100201,SL22120201,SL23020201,SL23060301,SL23 080301,SL23100401,SL23100305,SL23120401