Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set

• • Ongoing Z-2522-2025 FDA Class II ·initiated 6 Aug 2025

  Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

• • Ongoing Z-0963-2023 FDA Class I ·initiated 9 Dec 2022

  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

• • Terminated Z-1767-2017 FDA Class II ·initiated 17 Mar 2017

  Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.

• • Terminated Z-1831-2016 FDA Class II ·initiated 22 Apr 2016

  Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.

• • Terminated Z-1286-2015 FDA Class II ·initiated 2 Feb 2015

  Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.

• • Terminated Z-0879-2008 FDA Unclassified (pre-2012) ·initiated 14 Dec 2007

  Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

510(k) Number

K040636 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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