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Syringe with needle

ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD · Model LL - 3ml 23G X 1" · UDI-DI 06958697602745

MEG

510(k) clearances

2,952

Adverse events

Recalls

138

Facilities

Description

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Recalls

Date	Firm	Reason
2024-09-25	Cardinal Health 200, LLC	Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (I
2022-06-10	Guangdong Haiou Medical Apparatus Co., Ltd	Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resultin
2022-06-10	Guangdong Haiou Medical Apparatus Co., Ltd	Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resultin
2021-05-17	Smiths Medical ASD Inc.	Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approx
2015-11-23	Terumo Medical Corp	Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
2013-07-10	Smiths Medical ASD, Inc.	Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
2013-07-10	Smiths Medical ASD, Inc.	Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
2013-07-10	Smiths Medical ASD, Inc.	Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
2013-07-10	Smiths Medical ASD, Inc.	Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
2013-07-10	Smiths Medical ASD, Inc.	Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.