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FDA (Device enforcement)Recalled 2024-04-05class ii

Jiangsu Shenli Medical Production Co., Ltd.: Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Sterile syringes without needles for single

Hazard

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

Details from the source

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. Quantity: 7000 Lot/code info: Lot Code: LOT: 63721120001

UPC codes

63721120001

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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