Class II

Medical Device Recall: Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co., Ltd. · April 5, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

0

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2087-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.