Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters

• • Terminated Z-0152-2022 FDA Class II ·initiated 8 Dec 2020

  The labeling was missing information on sterilization and prohibition of reuse.

• • Terminated Z-1820-2020 FDA Class II ·initiated 28 Feb 2020 ·on shared 510(k) K172410

  Cases of Portex Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.

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

510(k) Number

K172410 ↗

FDA Product Code

BSP

Device Class

Class II

Regulation

21 CFR Part 868.5150

Advisory Committee

Anesthesiology

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. →