CADD 21-7395-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10610586027543), received between Jul 27, 2020 and Sep 7, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50649964 ↗
• MalfunctionJun 1, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE WAS NOT ADMINISTERING THE TREATMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037179 ↗
• MalfunctionMay 26, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE WAS NOT ADMINISTERING THE TREATMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011128 ↗
• MalfunctionDec 28, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT A CUSTOMER HAD AN INCIDENT WHEREBY THE TUBING CRACKED OPEN IN THE MIDDLE OF THE SET, NOT NEAR ANY CONNECTION. THE PATIENT WAS HOME AND IT HAPPENED OVERNIGHT WHILE HE WAS SLEEPING. NOT SURE OF THE CAUSE. THE REPORTER HAD NO OTHER COMPLAINTS AND WE HAVEN'T SEEN ANYTHING LIKE THIS BEFORE. THE PATIENT WAS NOT HARMED AND TREATMENT WAS NOT DELAYED. WE ARE UNSURE OF HOW LONG THE TUBING WAS LEAKING SO WE HAVE NO WAY OF KNOWING HOW MUCH OF THE MEDICATION WAS LOST AND NOT ADMINISTERED TO THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060878 ↗
• MalfunctionJul 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE FILTER OF THE CADD ADMINISTRATION SET. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10328508 ↗

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