CADD 21-7383-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 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 disposable tubing used with CADD pumps to deliver IV fluids and drugs. The 63 reports mostly describe false air alarms, tubing that blocked so fluid did not flow, and leaks at the connection, plus bags emptying sooner than expected. There were no deaths and 3 reports involved injuries. Two open recalls, both started in December 2022, cover lack of delivery from tubing occlusion 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
- 63
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10610586027475), received between Jun 1, 2017 and Mar 21, 2023 — classified as 3 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (17 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 18, 2026.
Recalls naming this device
- 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 ↗
- 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-0966-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Alarm System17
- Obstruction of Flow16
- Insufficient Flow or Under Infusion11
- Fluid/Blood Leak9
- Improper Flow or Infusion4
- Inappropriate Audible Prompt/Feedback4
- Partial Blockage4
- Defective Alarm3
Patient problems
- No Consequences Or Impact To Patient43
- No Information8
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
- Dyspnea1
- Inflammation1
- Respiratory Distress1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2023Device Alarm System; Inaccurate Delivery; Device Alarm System; Inaccurate Delivery
IT WAS REPORTED THE DISPOSABLE CAUSED THE PUMP TO ALARM LOW RESERVOIR VOLUME AND STOPPED APPROXIMATELY 4.23 HOURS SOONER THAN EXPECTED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16588010 ↗MalfunctionSep 27, 2022Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT AN AIR ALARM WAS DETECTED THREE TIMES WITH THE SAME LOT NUMBER. THE INCIDENT WAS NOTED BETWEEN THREE AND FOUR HOURS OF USE OF THE PRODUCT. THE USER OBSERVED THAT THE FILTER WAS HALF FULL OF SOLUTION (WHITE COLOR OBSERVED HALFWAY). THE USER USED A DIFFERENT LOT NUMBER. NO PATIENT INJURY WAS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491790 ↗MalfunctionSep 9, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE WAS ALARMING WITHOUT VISIBLE AIR IN THE SYSTEM AT THE AIR DETECTOR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397422 ↗MalfunctionSep 9, 2022Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT AN AIR ALARM WAS DETECTED THREE TIMES WITH THE SAME LOT NUMBER. THE INCIDENT WAS NOTED BETWEEN THREE AND FOUR HOURS OF USE OF THE PRODUCT. THE USER OBSERVED THAT THE FILTER WAS HALF FULL OF SOLUTION (WHITE COLOR OBSERVED HALFWAY). THE USER USED A DIFFERENT LOT NUMBER. NO PATIENT INJURY WAS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15396879 ↗MalfunctionSep 9, 2022Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT AN AIR ALARM WAS DETECTED THREE TIMES WITH THE SAME LOT NUMBER. THE INCIDENT WAS NOTED BETWEEN THREE AND FOUR HOURS OF USE OF THE PRODUCT. THE USER OBSERVED THAT THE FILTER WAS HALF FULL OF SOLUTION (WHITE COLOR OBSERVED HALFWAY). THE USER USED A DIFFERENT LOT NUMBER. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15396838 ↗MalfunctionSep 9, 2022Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT AN AIR ALARM WAS DETECTED THREE TIMES WITH THE SAME LOT NUMBER. THE INCIDENT WAS NOTED BETWEEN THREE AND FOUR HOURS OF USE OF THE PRODUCT. THE USER OBSERVED THAT THE FILTER WAS HALF FULL OF SOLUTION (WHITE COLOR OBSERVED HALFWAY). THE USER USED A DIFFERENT LOT NUMBER. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392246 ↗MalfunctionJun 8, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS BEING USED WITH PUMPS WHICH WERE CONSTANTLY GIVING ERROR MESSAGES SUCH AS "AIR IN THE SYSTEM". THE PUMPS AND BATTERIES WERE REPLACED SEVERAL TIMES AS IT WAS INITIALLY ASSUMED THAT THE PROBLEM WAS WITH THE PUMPS. THE ERROR MESSAGES PERSISTED EVEN WITH NEW PUMPS AND BATTERIES. THE NURSES WERE WELL TRAINED AND HAD BEEN WITH THE PATIENTS FOR A LONG TIME, SO THAT EXCLUDED APPLICATION ERRORS. THE ADMINISTRATION SET WAS CHANGED AND THE PUMPS RAN WITHOUT ERRORS.
Patient problems: Insufficient Information
MAUDE report 11957959 ↗MalfunctionJun 3, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
INFORMATION WAS RECEIVED INDICATING THAT UNDER DELIVERY MAY HAVE OCCURRED DURING THE USE OF THE ADMINISTRATION SET WITH A SMITHS MEDICAL CADD-SOLIS VIP AMBULATORY INFUSION PUMP. IT WAS REPORTED THAT "DESPITE CORRECT RUNNING TIME" A RESIDUAL VOLUME OF 500ML REMAINED AFTER AN OVERNIGHT INFUSION OF 1800ML OF FOOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11930425 ↗MalfunctionMay 7, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LIQUID WAS FOUND ON THE BOTTOM OF THE BACKPACK, ALTHOUGH THE PUNCTURE NEEDLE WAS SET CORRECTLY INTO THE INFUSION PORT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11790521 ↗MalfunctionMay 7, 2021Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE CADD PUMP PRODUCED AN AIR-IN-LINE ALARM WHILE THE CADD ADMINISTRATION SET WAS IN USE. THE AIR FORMED BETWEEN THE PUNCTURE MANDREL AND THE PUMP SEGMENT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11790241 ↗MalfunctionFeb 16, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY ON USE, THE SMITHS MEDICAL CADD ADMINISTRATION SET HAD AIR BUBBLES INSIDE TUBE ALARM. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 11332681 ↗MalfunctionDec 22, 2020Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THE DEVICE WAS BEING PRIMED AND REQUIRED 10 ML OF FLUID RATHER THAN THE EXPECTED 8 ML. THE REPORTER STATED THE SET PRIMED MORE SLOWLY THAN USUAL. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11058493 ↗MalfunctionDec 22, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THE DEVICE DID NOT DELIVER THE ENTIRE INFUSION DURING THE SCHEDULED INFUSION TIME. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11058204 ↗MalfunctionDec 22, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THE DEVICE DID NOT DELIVER THE ENTIRE INFUSION DURING THE SCHEDULED INFUSION TIME. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11058028 ↗MalfunctionDec 22, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THE DEVICE DID NOT DELIVER THE ENTIRE INFUSION DURING THE SCHEDULED INFUSION TIME. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11058022 ↗MalfunctionDec 22, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THE DEVICE DID NOT DELIVER THE ENTIRE INFUSION DURING THE SCHEDULED INFUSION TIME. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11057968 ↗MalfunctionDec 22, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THE DEVICE DID NOT DELIVER THE ENTIRE INFUSION DURING THE SCHEDULED INFUSION TIME. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11057909 ↗MalfunctionDec 22, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THE DEVICE DID NOT DELIVER THE ENTIRE INFUSION DURING THE SCHEDULED INFUSION TIME. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11057834 ↗MalfunctionDec 14, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TUBING LED TO A NUTRITION BAG NOT BECOMING COMPLETELY EMPTY AFTER THE END OF INFUSION. THE PATIENT INVOLVED WAS A CHILD WHO USE THIS FLUID DELIVERY EVERY DAY. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11002645 ↗MalfunctionDec 7, 2020Inaccurate Delivery; Inaccurate Delivery
INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT PUMP HAD DIFFICULTY DELIVERING THE INFUSION DURING PREFILLING. CUSTOMER NOTES, "INSTEAD OF THE USUAL 12-13 ML, IT WAS 40 ML." AFTER 14 HOURS IN USE, MORE THAN HALF OF THE INFUSION REMAINED IN THE BAG. THE PROBLEM PERSISTED EVEN AFTER REPLACING THE PUMP.
Patient problems: No Information
MAUDE report 10962736 ↗MalfunctionDec 7, 2020Inaccurate Delivery; Inaccurate Delivery
MalfunctionAug 6, 2020Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET CAUSED THE CADD SOLIS VIP PUMP TO ALARM "AIR BUBBLE" IN THE MIDDLE OF THE NIGHT DURING A PARENTERAL NUTRITION INFUSION. THIS OCCURRED 13 DIFFERENT TIMES BETWEEN FEBRUARY AND MARCH 2020 WITH 6 DIFFERENT PATIENTS AND VARYING LOT NUMBERS OF CADD ADMINISTRATION SETS. VARIOUS NUTRITION SUCH AS "OLIMEL N7 SMOTHKABIVEN, CLINIMIX, PERIKABIVEN, CERNEVIT, AND NUTRYELT" WERE BEING INFUSED DURING THESE REPORTED EVENTS. THE DURATION OF INFUSIONS WERE SET TO 15 HOURS. THIS TUBING WAS CONNECTED TO PORT CATH ( IMPLANTABLE PORT) OR VIA THE JUGULAR VEIN. THE PUMPS USED DURING THE INCIDENT WERE NEW. THE USER NOTICED THE BUBBLES WERE MICROBUBBLES OR LARGE BUBBLES AND THEN THESE BUBBLES STAGNATED. A FLUSH OF THE TUBING WAS SYSTEMATICALLY CONDUCTED AFTER THE INCIDENT. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10375055 ↗MalfunctionAug 6, 2020Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET CAUSED THE CADD SOLIS VIP PUMP TO ALARM "AIR BUBBLE" IN THE MIDDLE OF THE NIGHT DURING A PARENTERAL NUTRITION INFUSION. THIS OCCURRED 13 DIFFERENT TIMES BETWEEN FEBRUARY AND MARCH 2020 WITH 6 DIFFERENT PATIENTS AND VARYING LOT NUMBERS OF CADD ADMINISTRATION SETS. VARIOUS NUTRITION SUCH AS "OLIMEL N7 SMOTHKABIVEN, CLINIMIX, PERIKABIVEN, CERNEVIT, AND NUTRYELT" WERE BEING INFUSED DURING THESE REPORTED EVENTS. THE DURATION OF INFUSIONS WERE SET TO 15 HOURS. THIS TUBING WAS CONNECTED TO PORT CATH ( IMPLANTABLE PORT) OR VIA THE JUGULAR VEIN. THE PUMPS USED DURING THE INCIDENT WERE NEW. THE USER NOTICED THE BUBBLES WERE MICROBUBBLES OR LARGE BUBBLES AND THEN THESE BUBBLES STAGNATED. A FLUSH OF THE TUBING WAS SYSTEMATICALLY CONDUCTED AFTER THE INCIDENT. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10375050 ↗MalfunctionAug 6, 2020Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET CAUSED THE CADD SOLIS VIP PUMP TO ALARM "AIR BUBBLE" IN THE MIDDLE OF THE NIGHT DURING A PARENTERAL NUTRITION INFUSION. THIS OCCURRED 13 DIFFERENT TIMES BETWEEN FEBRUARY AND MARCH 2020 WITH DIFFERENT PATIENTS AND VARYING LOT NUMBERS OF CADD ADMINISTRATION SETS. VARIOUS NUTRITION SUCH AS "OLIMEL N7 SMOTHKABIVEN, CLINIMIX, PERIKABIVEN, CERNEVIT, AND NUTRYELT" WERE BEING INFUSED DURING THESE REPORTED EVENTS. THE DURATION OF INFUSIONS WERE SET TO 15 HOURS. THIS TUBING WAS CONNECTED TO PORT CATH ( IMPLANTABLE PORT) OR VIA THE JUGULAR VEIN. THE PUMPS USED DURING THE INCIDENT WERE NEW. THE USER NOTICED THE BUBBLES WERE MICROBUBBLES OR LARGE BUBBLES AND THEN THESE BUBBLES STAGNATED. A FLUSH OF THE TUBING WAS SYSTEMATICALLY CONDUCTED AFTER THE INCIDENT. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10375006 ↗MalfunctionAug 6, 2020Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET CAUSED THE CADD SOLIS VIP PUMP TO ALARM "AIR BUBBLE" IN THE MIDDLE OF THE NIGHT DURING A PARENTERAL NUTRITION INFUSION. THIS OCCURRED 13 DIFFERENT TIMES BETWEEN (B)(6) 2020 WITH 6 DIFFERENT PATIENTS AND VARYING LOT NUMBERS OF CADD ADMINISTRATION SETS. VARIOUS NUTRITION SUCH AS "OLIMEL N7 SMOTHKABIVEN, CLINIMIX, PERIKABIVEN, CERNEVIT, AND NUTRYELT" WERE BEING INFUSED DURING THESE REPORTED EVENTS. THE DURATION OF INFUSIONS WERE SET TO 15 HOURS. THIS TUBING WAS CONNECTED TO PORT CATH ( IMPLANTABLE PORT) OR VIA THE JUGULAR VEIN. THE PUMPS USED DURING THE INCIDENT WERE NEW. THE USER NOTICED THE BUBBLES WERE MICROBUBBLES OR LARGE BUBBLES AND THEN THESE BUBBLES STAGNATED. A FLUSH OF THE TUBING WAS SYSTEMATICALLY CONDUCTED AFTER THE INCIDENT. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10375003 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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