CADD 21-7390-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586027505), received between Jul 19, 2019 and Jul 22, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K040636); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 9, 2022Class IOpen, Classified

   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

   Z-0963-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Break; Leak/Splash; Use of Device Problem; Break; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT PCA TUBING WAS FOUND TO BE LEAKING AT CONNECTION SITE WITH IV FLUIDS. THE ORIGINAL INTENDED PROCEDURE WAS IV INFUSION. THE DEVICE HAD FAILED. IT BROKE AND THE CUSTOMER COULD NOT GET IT TO WORK, OR THE DEVICE HAD STOPPED WORKING. THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THE DEVICE WAS HARD TO USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801321 ↗
• MalfunctionJun 24, 2024

  PCA TUBING FOUND TO BE LEAKING AT CONNECTION SITE WITH IV FLUIDS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593525 ↗
• MalfunctionJul 19, 2019Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION TUBING WAS DISCONNECTED AT POINT OF CONNECTION SITE PROXIMAL TO THE BLUE/YELLOW LOCK. THE TUBING CONNECTION SITE WAS FOUND TO BE INTACT UPON REGISTERED NURSE ASSESSMENT AND SITE SPONTANEOUSLY DISCONNECTED ON PATIENT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 8809811 ↗
• MalfunctionJul 19, 2019Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE REGISTERED NURSE FOUND THE PATIENT'S EPIDURAL TUBING DISCONNECTED AT THE CONNECTION SITE. THE SITE WAS APPROXIMATELY DISCONNECTED FOR AN HOUR. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 8806927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040636. One submission often covers many models, so check the product and lot details in each record.

• Z-2522-2025 · Aug 6, 2025 · Open, Classified
  Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
• Z-1767-2017 · Mar 17, 2017 · Terminated
  CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
• Z-1831-2016 · Apr 22, 2016 · Terminated
  CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24
• Z-1286-2015 · Feb 2, 2015 · Terminated
  CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
• Z-0879-2008 · Dec 14, 2007 · Terminated
  Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Pa