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Needle Guide Assistant

Union Medico ApS · Model 1 · UDI-DI 05714472000004

KZH

510(k) clearances

1,079

Adverse events (1 deaths)

Recalls

Facilities

Description

The Device is intended to allow patients or carers to self-administer inject able FDA approved drugs or biologics with a safe, simple and easy injection system. Personal Injector is intended to be used in any setting including the home. Personal Injector is designed for the user - by a user, and here for a lot of emphasis has been put on functionality and injection comfort, appearance. surface, materials, weight, balance, and sound. Personal Injector is an injection system allowing the user to have maximum control and comfort while injecting. Personal Injector differs from commonly known Auto-injector. Until today, marketed Autoinjectors are only for subcutaneous injections. and introduce both the needle and the drug in one motion. The injections are associated with discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site. Personal Injector has a spring-loaded mechanism that only serves to introduce the needle to a pre-determined depth, either subcutaneous or intramuscular. Hereafter the patient can check for air bobbles and vein penetration, and perform a safe traditional manual injection of the drug, by slowly and steady pushing the plunger down. Personal Injector minimises pain and support the patient perform the manual drug introduction, avoiding almost all discomfort. Personal Injector two unique Syringe-I lolders is designed to accommodate FDA approved syringes with fixed and non-fixed needles. Personal Injector is suitable for many injection regimes, including multiple sclerosis patients treatment with interferon beta, cancer treatment, children receiving growth hormone treatment, men injecting local vasodilators to treat erectile dysfunction, and injections of heparin, adrenaline, insulin. apomorphine, and many others medications.

Recalls

Date	Firm	Reason
2019-07-17	Owen Mumford USA, Inc.	There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector)
2019-07-17	Owen Mumford USA, Inc.	There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector)
2017-06-23	International Medsurg Connection, Inc.	Insufficient documentation to support product sterility claims.
2014-11-24	Owen Mumford USA, Inc.	The syringe carrier is missing components: a damper and spring.
2011-06-15	Becton Dickinson & Company	Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
2005-03-08	Tri-State Hospital Supply Corp	Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
2003-10-22	Arrow International Inc	package lid identifies the contents incorrectly
2003-09-16	Arrow International Inc	wrong product in box
2003-09-16	Arrow International Inc	wrong product in box
2003-09-16	Arrow International Inc	wrong product in box

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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.