PlainRecalls
FDA Devices Moderate Class II Ongoing

Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No

Reported: May 29, 2024 Initiated: April 5, 2024 #Z-2067-2024

Product Description

Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 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).

Details

Units Affected
39200
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.
Location
Changzhou

Frequently Asked Questions

What product was recalled?
Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No. Recalled by Jiangsu Shenli Medical Production Co., Ltd.. Units affected: 39200.
Why was this product recalled?
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Which agency issued this recall?
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-2067-2024.