CADD 21-7336-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10610586027291), received between Dec 6, 2018 and Aug 25, 2022 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (15 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE SUSPECT DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE INCIDENT, HOWEVER, THERE WAS NO PATIENT HARM. THE SUSPECT DEVICE WAS REMOVED WITH THE TIP IN TACK, THE ALARM SOUNDED WHICH INDICATED THAT THE BAG WAS EMPTY, IN WHICH, THE CUSTOMER DECIDED TO REPLACE THE SUSPECT DEVICE AND THE ISSUE WAS RESOLVED: NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294919 ↗
• MalfunctionJun 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE IV LINE HAD SEPARATED FROM THE LUER LOCK END. CLIENT REINSERTED THE TUBING BACK INTO THE LUER LOCK END AND TAPED IT, SAW NO FURTHER LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14745772 ↗
• MalfunctionJul 2, 2021Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, UNDER INFUSION WAS NOTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108386 ↗
• MalfunctionMay 7, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - FLOW STOP UNDER INFUSED REMICADE THAT HAD A VOLUME OF 250 ML TO BE DELIVERED TO THE PATIENT. THE INFUSION ENDED WITH 37 ML LEFT IN RESIDUAL BAG; WHICH WAS CALCULATED AT 15% UNDER. NO PATIENT INJURY WAS REPORTED. COMPLAINT RELATED TO OTHER FILES AND DELIVERY PROGRAMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795031 ↗
• MalfunctionJan 20, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET BROKE IN TWO WHERE THE LINE ATTACHES TO THE 0.2MICRON AIR ELIMINATING FILTER. THE EXTENSION LINE SEPARATED FROM THE PROXIMAL END OF THE FILTER. THE ISSUE OCCURRED ON THE SECOND DAY OF THE LINE BEING USED FOR THE ADMINISTRATION BLINATUMOMAB CONTINUOUS INFUSION. THE PATIENT WENT TO THE HOSPITAL AND A PHARMACIST MADE A NEW BAG OF MEDICATION TO BE CONNECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11201774 ↗
• MalfunctionSep 1, 2020Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT DURING INFUSION OF AN ONCOLOGY TREATMENT VIA A SMITHS MEDICAL CADD ADMINISTRATION SET, A BREAK IN THE LINE WAS OBSERVED. THE BREAK WAS NOTED TO BE LOCATED BETWEEN THE CASSETTE AND IV BAG. IT WAS REPORTED THAT DURING A NURSING CHECK, THE BACKPACK WHICH CONTAINED THE PUMP, IV BAG, AND ADMINISTRATION SET WAS FOUND WET. THE INFUSION WAS THEN STOPPED, AND A NEW ADMINISTRATION SET AND IV BAG WAS USED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476830 ↗
• MalfunctionJun 17, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET - FLOW STOP WAS BROKEN BY THE AIR FILTER. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10166002 ↗
• MalfunctionJun 17, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET - FLOW STOP WAS BROKEN BY THE AIR FILTER. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163238 ↗
• MalfunctionJun 17, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET - FLOW STOP WAS BROKEN BY THE AIR FILTER. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162281 ↗
• MalfunctionJun 17, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET - FLOW STOP WAS BROKEN BY THE AIR FILTER. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10161052 ↗
• MalfunctionJun 17, 2020Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET - FLOW STOP WAS BROKEN BY THE AIR FILTER. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10160988 ↗
• MalfunctionApr 29, 2020Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET FOR AMBISOME (LIPOSOME) INFUSION, THE PATIENT WAS SUPPOSED TO RECEIVE 120ML OVER 2 HOURS, BUT 40 ML WAS LEFT OVER IN THE BAG. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009218 ↗
• MalfunctionNov 19, 2019Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL 94" SPIKE TUBING BROKE OFF OF THE FILTER WHEN THE PATIENT WAS HOME WITH AN AMBULATORY INFUSION PUMP. ADDITIONAL INFORMATION WAS RECEIVED THAT THE NEW CHEMOTHERAPY INFUSION WAS RESTARTED WITH A BRIEF INTERRUPTION. THE PATIENT WAS ASSESSED THERE WAS NO EXPOSURE TO THE SKIN DUE TO THIS ISSUE. THE PATIENT WILL RECEIVE ADDITIONAL CHEMOTHERAPY ON LAST INFUSION. THERE WAS NO HARD OR ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342341 ↗
• MalfunctionNov 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE, A PATIENT THAT WAS RECEIVING ANTIBIOTICS ON A PORTABLE INFUSION PUMP, EXPERIENCED PERFORATION ON A SMITHS MEDICAL CADD ADMINISTRATION SET. THE REPORTER INDICATED THAT THE FAMILY DISCOVERED THAT MEDICATION WAS SUDDENLY COMING OUT OF THE BACKPACK WHERE THE PUMP IS LOCATED. IN ADDITION, THE REPORTER INDICATED THAT HALF AND HOUR BEFORE THE INCIDENT, THE PATIENT HAD MEDICATION CHANGED BUT NOT THE ADMINISTRATION KIT. SUBSEQUENTLY, THE MEDICINE AND SETS WERE CHANGED AGAIN AND THERE WAS NO CONSEQUENCE TO THE PATIENT, BUT IT WAS REPORTED THAT THE PATIENT WAS COMPLETELY NEUTROPENIC, AND THE KIT WAS ATTACHED TO HER CENTRAL NERVOUS CATHETER, THEREFORE THE RISK OF CONTAMINATION AND INFECTION WAS PRESENT. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267682 ↗
• MalfunctionOct 23, 2019Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS INFUSING BLINATUMOMAB FOR A PATIENT FOR APPROXIMATELY FOUR HOURS WHEN THE SET BROKE. THE PATIENT HAS BEEN RECEIVING THIS INFUSION FOR SEVERAL MONTHS AND NOTED THEY DID NOT GET THE SET "STUCK ON ANYTHING". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9227283 ↗
• MalfunctionSep 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS IN USE FOR INFUSION WITH HOME CARE PATIENT. THE REPORTER STATED THE ADMINISTRATION KIT "BROKE" DURING INFUSION OF ANTIBIOTIC. THE REPORTER STATED THE PATIENT'S CAREGIVER STOPPED THE INFUSION, APPLIED A CLAMP TO THE SET AND APPLIED A CAP TO THE PATIENT'S CENTRAL VENOUS CATHETER. THE REPORTER STATED THE PATIENT REPORTED TO HOSPITAL TO GET A REPLACEMENT ADMINISTRATION SET AND CONTINUE THE INFUSION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9101883 ↗
• MalfunctionSep 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS IN USE FOR INFUSION WITH HOME CARE PATIENT. THE REPORTER STATED THE ADMINISTRATION KIT "BROKE" DURING INFUSION OF ANTIBIOTIC. THE REPORTER STATED THE PATIENT'S CAREGIVER STOPPED THE INFUSION, APPLIED A CLAMP TO THE SET AND APPLIED A CAP TO THE PATIENT'S CENTRAL VENOUS CATHETER. THE REPORTER STATED THE PATIENT REPORTED TO HOSPITAL TO GET A REPLACEMENT ADMINISTRATION SET AND CONTINUE THE INFUSION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9101878 ↗
• MalfunctionSep 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS IN USE FOR INFUSION WITH HOME CARE PATIENT. THE REPORTER STATED THE ADMINISTRATION KIT "BROKE" DURING INFUSION OF ANTIBIOTIC. THE REPORTER STATED THE PATIENT'S CAREGIVER STOPPED THE INFUSION, APPLIED A CLAMP TO THE SET AND APPLIED A CAP TO THE PATIENT'S CENTRAL VENOUS CATHETER. THE REPORTER STATED THE PATIENT REPORTED TO HOSPITAL TO GET A REPLACEMENT ADMINISTRATION SET AND CONTINUE THE INFUSION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9101868 ↗
• MalfunctionSep 4, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.

  Patient problems: No Information

  MAUDE report 8960189 ↗
• MalfunctionSep 4, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.

  Patient problems: No Information

  MAUDE report 8960175 ↗
• MalfunctionSep 4, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.

  Patient problems: No Information

  MAUDE report 8960160 ↗
• MalfunctionSep 3, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.

  Patient problems: No Information

  MAUDE report 8958133 ↗
• MalfunctionSep 3, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.

  Patient problems: No Information

  MAUDE report 8958132 ↗
• MalfunctionSep 3, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.

  Patient problems: No Information

  MAUDE report 8958131 ↗
• MalfunctionSep 3, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.

  Patient problems: No Information

  MAUDE report 8958130 ↗

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