Home › Device types › KZH
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
V-Cath — Neo Medical Inc.Coolject 1-3cc Syringe Holder Nozzle Accessory — Vapocoolshot, IncBETACONNECT — Phillips-Medisize A/SOrbit Inserter — Modular Medical, Inc.V-Cath — Neo Medical Inc.Glatopaject® — Sandoz GmbHNeoMagic — Neo Medical Inc.Inject-Ease — AMBI, INC.Orbit®Inserter — Ypsomed AGAutoject 2 — OWEN MUMFORD LIMITEDCoolject 1-3cc Syringe Holder Nozzle Accessory — Vapocoolshot, IncNeoMagic — Neo Medical Inc.Rebiject II — EMD Serono, Inc.SKYTROFA Auto-Injector — Phillips-Medisize A/SNeoMagic — Neo Medical Inc.Needle Guide Assistant — Union Medico ApSNeoMagic — Neo Medical Inc.Autoject 2 — OWEN MUMFORD LIMITEDMODD1 Patient Welcome Kit — Modular Medical, Inc.Whisperject — Mylan Pharmaceuticals Inc.Onpro kit — AMGEN INC.NeoMagic — Neo Medical Inc.V-Cath — Neo Medical Inc.NeoMagic — Neo Medical Inc.
Recent 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 Pe |
| 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 Pe |
| 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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