CADD® Infusion Disposables Portfolio with NRFit™ connectors

• • Ongoing Z-3212-2026 FDA Class II ·initiated 20 Aug 2026 ·on shared 510(k) K162219

  Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

• • Ongoing Z-0965-2023 FDA Class I ·initiated 9 Dec 2022 ·on shared 510(k) K162219

  There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K162219 ↗

FDA Product Code

PWH

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket

  Class II

  FDA 510(k) K061513 Active Cleared 1 Aug 2006

• SAF-T Closed Blood Collection System with SAF-Holder Device, Model 99200

  Class II

  FDA 510(k) K072783 Active Cleared 30 Nov 2007

• Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits

  Class II

  FDA 510(k) K071958 Active Cleared 21 Nov 2007

• Port-A-Cath Power P.A.C. Implantable Venous Access Systems

  Class II

  FDA 510(k) K093414 Active Cleared 1 Mar 2010

• Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012

  Class II

  FDA 510(k) K092256 Active Cleared 20 Oct 2010

• EchoGlo Needle

  Class II

  FDA 510(k) K171968 Active Cleared 25 Jan 2018

See all devices from Smiths Medical Asd, Inc. →