Jiangsu Shenli Medical Production Co., Ltd.: Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use

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: 9050240 Lot/code info: Lot Code: LOT: 63721010001,63721010003,63721040002,63721050 002,63721060001,63721070001,63721070002, 63721070003,63721070004,63721070006,63721080 001,63721080002,63721080003,63721080004, 63721080005,63721090001,63721090003,63721090 004,63721090005,63721100001,63721110001, 63721110002,63721110003,63721120002,63721120 003,63721120004,63722010001,63722020002, 63722030001,63722030002,63722030003,63722030 004,63722040002,63722040004,63722050001, 63722050002,63722050003,63722060002,63722060003,63722060006,63722070002,63722070004, 63722070005,63722070006,63722080003,63722080 005,63722080006,63722090003,63722100003, 63722120003,63722120004,63723010001,63723020 001,63723020002,63723050001,63723060001, 63723070001,63723070002,63723070003,63723080 002,63723080003,63723090002,63723090003, 63723090004,63723100003,63723100004,63723110 001,63723110003,63723120002

UPC codes

63721010001, 63721010003, 63721040002, 63721060001, 63721070001, 63721070002, 63721070003, 63721070004, 63721070006, 63721080002, 63721080003, 63721080004, 63721080005, 63721090001, 63721090003, 63721090005, 63721100001, 63721110001, 63721110002, 63721110003, 63721120002, 63721120004, 63722010001, 63722020002, 63722030001, 63722030002, 63722030003, 63722040002, 63722040004, 63722050001, 63722050002, 63722050003, 63722060002, 63722060003, 63722060006, 63722070002, 63722070004, 63722070005, 63722070006, 63722080003

Source

Official record: FDA (Device enforcement) ↗

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