Z-2117-2024 Class II Ongoing
FDA device recall Z-2117-2024 was initiated by Jiangsu Shenli Medical Production Co., Ltd. on Apr 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: 360500.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- Apr 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360500
Product Description
Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-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: SL21030105,SL21040104,SL21070104,SL21090105,SL21110104,SL21 110304,SL21120104,SL22030105,SL22070106,SL22100205,SL221202 03,SL23020204,SL23080305,SL23100405,SL23120405
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2117-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026