FDA recall Z-2124-2024

Jiangsu Shenli Medical Production Co., Ltd. · Class II · device

Product

Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-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

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.

Key facts

Status
Ongoing
Initiation date
2024-04-05
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Changzhou, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2124-2024