Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Descript

FDA device recall Z-2100-2024 · posted 2024-05-20 · Open, Classified

Recall details

Recalling firm

Jiangsu Shenli Medical Production Co., Ltd.

Reason for recall

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Action taken

On 05/14/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that Jiangsu Shenli Medical Production Co., Ltd. is recalling piston syringes that were distributed without premarket clearance. The Recalling Firm stated that they received an FDA Warning Letter that the piston syringes were not legally marketed devices. Customers are instructed to: Examine their inventory and stop/cease use of all syringe products subject to this action and report the inventory quantity to Jiangsu Shenli Medical Production Co., Ltd. Considering the complicated return process, and high cost of returning the products, the firm is instructing customers to dispose of these recalled syringes in the U.S, using their facility s approved/established procedures for disposal of medical products, or by contacting a local third party company to assist with the disposal of the recalled syringes. Please report the destruction method and cost with Shenli before final implementation. After product disposal, please provide Shenli with confirmation of destruction of products. For questions or assistance - contact the general manager at email shenli@syringechina.com or telephone number 0086-519-88731071

Root cause

No Marketing Application

Status

Open, Classified

Product code

FMF

Quantity affected

110000

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,

Date initiated

2024-04-05

Date posted

2024-05-20

Location

Changzhou, China