BEUDAMED
    FDA Enforcement Not Yet Classified Ongoing

    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

    Recall: 94520 · Reported May 29, 2024

    Enforcement

    Recall Number
    94520
    Event ID
    94520
    Classification
    Not Yet Classified
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Jiangsu Shenli Medical Production Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 29, 2024
    Initiation Date
    April 5, 2024
    Address
    No. 20 Changzheng Road, Zhengluzhen Wujin, Changzhou, N/A, China

    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

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

    Code Info

    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

    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.

    Quantity

    4092250