Complaint
| Safety Huber Needles |
| Huber needles are used to administer chemotherapy, antibiotics, and TPN through an implanted IV port. These needles may be left in the port for many days at a time. It can be difficult to deaccess, or extract the needle safely. The difficulty of pulling the needle out often creates a recoil action with the clinician often getting a needle stuck into the stabilizing hand. A Safety Huber needle retracts or shields the needle the needle upon removal from the implanted port preventing the potential of recoil resulting in an accidental needlestick. |
| Product description: Sterile pack, single use only Needle-stick prevention, safety assured Special needle tip design to prevent rubber fragment contamination Luer connector, equipped with needleless connector, heparin cap, Y three-way Chassis sponge design for a more comfortable application High pressure resistant central line with 325 P.S.I Two holes connector optional Customized sizes available |
| Regulatory: MDR 2017/745 |
| Standard: EN ISO 13485 : 2016/AC:2016 Medical equipment quality management system for regulatory requirements EN ISO 14971 : 2012 Medical devices - Application of risk management to medical devices ISO 11135:2014 Medical device Sterilization of ethylene oxide Confirmation and general control ISO 6009:2016 Disposable sterile injection needles Identify color code ISO 7864:2016 Disposable sterile injection needles ISO 9626:2016 Stainless steel needle tubes for the manufacture of medical devices |
