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Introducer, Syringe Needle

FDA product code KZH · Class 2 · General Hospital

52
Registered devices
1,079
Adverse events
10
Recalls
47
510(k) clearances

Devices with this code

NeoMagic — Neo Medical Inc.Minimed™ Quick-serter™ — MEDTRONIC MINIMED, INC.Accu-Chek Link Assist — Roche Diabetes Care GmbHSKYTROFA Auto-Injector — Phillips-Medisize A/SAutoject 2 — OWEN MUMFORD LIMITEDNeoMagic — Neo Medical Inc.Skytrofa Auto-Injector — Phillips-Medisize A/SMiniMed™ Quick-serter™ — MEDTRONIC MINIMED, INC.MiniMed™ Quick-serter™ — MEDTRONIC MINIMED, INC.FlexPro® PenMate® — NOVO NORDISK INC.NeoMagic — Neo Medical Inc.Glatopaject ® — AEROPHARM GmbHGlatopaject® — Sandoz GmbHBETACONNECT — Phillips-Medisize A/SOnpro kit — AMGEN INC.V-Cath — Neo Medical Inc.MODD1 Patient Welcome Kit — Modular Medical, Inc.AccuSert — EMED TECHNOLOGIES CORPORATIONNeoMagic — Neo Medical Inc.GripMate™ — SUN PHARMACEUTICAL INDUSTRIES, INC.MODD1 Starter Kit — Modular Medical, Inc.NeoMagic — Neo Medical Inc.NeoMagic — Neo Medical Inc.MiniMed™ Quick-serter™ — MEDTRONIC MINIMED, INC.

Recent recalls

DateFirmReason
2019-07-17Owen 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 Pe
2019-07-17Owen 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 Pe
2017-06-23International Medsurg Connection, Inc.Insufficient documentation to support product sterility claims.
2014-11-24Owen Mumford USA, Inc.The syringe carrier is missing components: a damper and spring.
2011-06-15Becton Dickinson & CompanyExperiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
2005-03-08Tri-State Hospital Supply CorpSome of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
2003-10-22Arrow International Incpackage lid identifies the contents incorrectly
2003-09-16Arrow International Incwrong product in box
2003-09-16Arrow International Incwrong product in box
2003-09-16Arrow International Incwrong product in box

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.