CADD 21-7333-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical CADD administration set is tubing used to deliver fluids through an infusion pump. The 24 reports mostly describe fluid leaks, false alarms, mechanical breakage, and too little fluid being delivered; some mention a connector breaking or a small fragment, with no deaths or injuries reported. There are 2 open recalls, both started in December 2022, concerning possible underdelivery from blocked tubing and false “no disposable attached” alarms.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10610586043239), received between Aug 7, 2017 and Feb 4, 2022 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).
2 FDA recall records name this device's identifier, 2 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 16, 2026.
Recalls naming this device
- Dec 9, 2022Open, 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 ↗
- Dec 9, 2022Open, 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-0966-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak14
- False Alarm3
- Mechanical Problem3
- Device Alarm System2
- Insufficient Flow or Under Infusion2
- Defective Component1
- Improper Flow or Infusion1
- Material Fragmentation1
Patient problems
- No Patient Involvement10
- No Consequences Or Impact To Patient8
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2022Defective Component; Defective Component
IT WAS REPORTED THAT AN ADMIN SET USED TO FILL THE CASSETTE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13456151 ↗MalfunctionMay 18, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS IN USE WITH A CADD SOLIS VIP PUMP WHEN AN "AIR" ALARM WAS DISPLAYED WITHOUT ANY VISIBLE AIR IN THE SYSTEM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11840702 ↗MalfunctionMar 16, 2021False Alarm; Mechanical Problem; False Alarm; Mechanical Problem
IT WAS REPORTED THE DEVICE CAUSED THE ATTACHED PUMP TO GIVE FALSE "AIR IN LINE" ALARMS.
Patient problems: Insufficient Information
MAUDE report 11497610 ↗MalfunctionMar 16, 2021False Alarm; Mechanical Problem; False Alarm; Mechanical Problem
IT WAS REPORTED THE DEVICE CAUSED THE ATTACHED PUMP TO GIVE FALSE "AIR IN LINE" ALARMS.
Patient problems: Insufficient Information
MAUDE report 11497586 ↗MalfunctionMar 16, 2021False Alarm; Mechanical Problem; False Alarm; Mechanical Problem
IT WAS REPORTED THE DEVICE CAUSED THE ATTACHED PUMP TO GIVE FALSE "AIR IN LINE" ALARMS.
Patient problems: Insufficient Information
MAUDE report 11495749 ↗MalfunctionAug 4, 2020Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT THE LUER-LOCK BROKE OFF A SMITHS MEDICAL CADD ADMINISTRATION SET WHILE IT WAS IN USE WITH THE PUMP. THE ISSUE OCCURRED IMMEDIATELY AND THERE WAS NO CLINICAL OR PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10365187 ↗MalfunctionJun 5, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT A SMITHS MEDICAL, ADMIN SET DIDN'T DELIVER CORRECT AMOUNT OF FLUID. THE PUMP WAS SUPPOSED TO DELIVER 1000ML BUT WHEN THE INFUSION WAS DONE IT STILL WAS ABOUT 500ML LEFT IN THE BAG. BIO AGNES DID AN ACCURACY TEST WITH THE SAME PUMP AND 21.7333-24 AND 21-7033.24 WITH MAJOR VARIATION. THE SPECIFIC ADMIN SET 21-2333-24 DELIVERED 27ML OF 50 ML AND THE 21-7033-24 DID DELIVER 49ML OF 50 ML. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10121874 ↗MalfunctionJun 5, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT A SMITHS MEDICAL, ADMIN SET DIDN'T DELIVER CORRECT AMOUNT OF FLUID. THE PUMP WAS SUPPOSED TO DELIVER 1000ML BUT WHEN THE INFUSION WAS DONE IT STILL WAS ABOUT 500ML LEFT IN THE BAG. BIO AGNES DID AN ACCURACY TEST WITH THE SAME PUMP AND 21.7333-24 AND 21-7033.24 WITH MAJOR VARIATION. THE SPECIFIC ADMIN SET 21-2333-24 DELIVERED 27ML OF 50 ML AND THE 21-7033-24 DID DELIVER 49ML OF 50 ML. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10121872 ↗MalfunctionOct 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS FOUND TO BE LEAKING IN TWO SEPARATE LINES. THE LEAKAGE WAS VISIBLE AND LOCALIZED TO RIGHT BELOW OF THE CASSETTE AND NUTRITION SOLUTION WAS SPRAYING OUT FROM THE TUBE. THE INFANT WAS BEING TREATED BY HOME HOSPITAL AT HOME AND THEY DISCONTINUED USING TUBINGS FROM THE SAME LOT. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9168047 ↗MalfunctionOct 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS FOUND TO BE LEAKING IN TWO SEPARATE LINES. THERE WAS LEAKAGE IN THE TUBING RIGHT BELOW THE FILTER. THE INFANT WAS BEING TREATED BY HOME HOSPITAL AT HOME AND THEY DISCONTINUED USING TUBINGS FROM THE SAME LOT. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9168045 ↗MalfunctionApr 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THIS CADD ADMINISTRATION SET WAS LEAKING. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8546042 ↗MalfunctionApr 11, 2019Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THIS CADD CASSETTE WAS ALARMING ON PATIENT'S BOTH THE PUMP. THE REPORTED EVENT DID NOT CAUSE ANY ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8505278 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499861 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499857 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499855 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499854 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499853 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499852 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499851 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8499850 ↗MalfunctionApr 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THIS CADD ADMINISTRATION SET EXHIBITED LEAKING. IT WAS REPORTED THAT THE LEAKING OCCURRED AT THE FILTER. THE ADMINISTRATION SET WAS DISCARDED AFTER THE EVENT. THE THERAPY INCLUDED FOLLOWING MEDICATION AND DEVICES: INFUSION BAG BAXTER 500 OR 1000 ML NACL 0.9% + THREE TYPES OF CYTOSTATICS, CYTO-AD-Z INLINE / 4 FROM CODAN, SWANLOCK AND PICC LINE (DOUBLE LUMEN). THE REPORTED EVENT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8497150 ↗MalfunctionApr 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THIS CADD ADMINISTRATION SET EXHIBITED LEAKING. IT WAS REPORTED THAT THE LEAKING OCCURRED AT THE FILTER. THE ADMINISTRATION SET WAS DISCARDED AFTER THE EVENT. THE THERAPY INCLUDED FOLLOWING MEDICATION AND DEVICES: INFUSION BAG BAXTER 500 OR 1000 ML NACL 0.9% + THREE TYPES OF CYTOSTATICS, CYTO-AD-Z INLINE / 4 FROM CODAN, SWANLOCK AND PICC LINE (DOUBLE LUMEN). THE REPORTED EVENT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8497149 ↗MalfunctionApr 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THE BAG WITHIN THIS CADD CASSETTE WAS LEAKING. THE REPORTED EVENT WAS NOTICED WHILE FILLING THE CASSETTE. THERE WAS NO PATIENT INVOLVED DURING THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8497148 ↗MalfunctionAug 7, 2017Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT AIR PASSED THROUGH THE FILTER OF A CADD® ADMINISTRATION SETS WITH AIR-ELIMINATING FILTER. AN AIR BUBBLE WAS FOUND PAST THE AIR FILTER. A PERIPHERALLY INSERTED CENTRAL CATHETER WAS USED FOR VEIN ACCESS. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6772072 ↗
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, ClassifiedSmiths 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 · TerminatedCADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
- Z-1831-2016 · Apr 22, 2016 · TerminatedCADD 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 · TerminatedCADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
- Z-0879-2008 · Dec 14, 2007 · TerminatedSmiths 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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