Z-2097-2024 Class II Ongoing
FDA device recall Z-2097-2024 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: 0.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- Apr 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2097-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026