Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: N...
FDA Recall # — Not Yet Classified — April 5, 2024
Product Description
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 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).
Recalling Firm
Jiangsu Shenli Medical Production Co., Ltd. — Changzhou
Classification
Not Yet Classified
Product Type
Devices
Product Quantity
4092250
Distribution
U.S.: 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.
Code Information
Lot Code: LOT: 63720120007,63721010002,63721050002,63721060002,63721070001,63721070004,63721070006, 63721080001,63721080002,63721080003,63721080004,63721080005,63721090001,63721090004, 63721090005,63721100001,63721100002,63721110002,63721110003,63721120001,63721120004, 63722010001,63722020002,63722030001,63722030003,63722030004,63722040004,63722040006, 63722050001,63722050006,63722060001,63722060002,63722060003,63722060006,63722070002, 63722070004,63722080002,63722080004,63722080005,63722080006,63722090002,63722120002, 63722120003,63723010002,63723020001,63723050001,63723050002,63723060001,63723070001, 63723070003,63723080001,63723080002,63723080003,63723090002,63723100003,63723110001, 63723120002
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated