Recall Z-2056-2024— Jiangsu Shenli Medical Production Co., Ltd.

Class II · Ongoing

Class II FDA medical device recall by Jiangsu Shenli Medical Production Co., Ltd., initiated 2024-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No. Reason: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)..

Recalling firm
Jiangsu Shenli Medical Production Co., Ltd.
Classification
Class II
Status
Ongoing
Initiated
2024-04-05
Firm location
Changzhou, China

Product description

Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.