CADD 21-7323-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10610586039614), received between Jun 9, 2020 and Nov 12, 2024 — classified as 21 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.

6 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

1. 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

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow

  IT WAS REPORTED THAT THE PUMP WILL NOT PRIME. PER REPORTER, THE NURSE TRIED SEVERAL SETS, AND AN ENGINEER WAS CALLED IN TO EXAMINE THE PUMP THAT WAS NOT PRIMING CORRECTLY. DESPITE TRYING MULTIPLE NEW CASSETTES, THE UNIT CONTINUED TO DISPLAY AN OCCLUSION ALARM. IT WAS NOTED THAT THE SET MIGHT DIFFER SLIGHTLY FROM THE PREVIOUS LOT NUMBER. HE TESTED THE UNIT WITH HIS OWN TEST SET, WHICH WORKED CORRECTLY, INDICATING THAT THE ISSUE MIGHT BE RELATED TO THE CURRENT LOT NUMBER BEING USED. THE EVENT OCCURRED DURING POST PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663811 ↗
• MalfunctionOct 27, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A PUMP DID NOT DELIVER THE PROGRAMMED VOLUME. THE EVENT LOG SAYS IT DELIVERED, BUT NO DRUG WAS DELIVERED AFTER FORTY-EIGHT HOURS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685517 ↗
• MalfunctionJun 14, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT AN ADMINISTRATION SET ASSOCIATED WITH A PUMP DELIVERY ACCURACY FAULT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685525 ↗
• MalfunctionJun 13, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THE AZACTAM CADD CASSETTE HAD A RESIDUAL OF 120 ML (12% OF TOTAL) EVEN THOUGH CADD PUMP SCREEN STATED ONLY 6.1 MLS REMAINED. PATIENT REFUSED HEARING ANY ALARMS. CADD PUMP WAS PROGRAMMED CORRECTLY. BLUE LUMEN OF PICC LINE FLUSHING SLUGGISH BUT BRISK POSITIVE BLOOD RETURN UPON PULL BACK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14677961 ↗
• MalfunctionMay 27, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THERE WAS A RESIDUAL OF ABOUT 40 CC IN BAG. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14527748 ↗
• MalfunctionMay 27, 2022Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT THE LUMEN WAS VERY DIFFICULT TO FLUSH AND DID NOT HAVE BLOOD RETURN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526907 ↗
• MalfunctionMay 7, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT TYGACIL CADD DID NOT EMPTY COMPLETELY, WITH ABOUT HALF OF THE DRUG REMAINING. PICC LINE WAS POSITIONAL AND HAD SLUGGISH BLOOD RETURN. TPA USED FOR WHITE AND PINK LUMENS. ONLY PINK LUMEN WAS POSITIVE FOR BR AT END OF VISIT. MIDLEVEL MADE AWARE. PUMP WAS SERVICED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14320687 ↗
• MalfunctionMay 7, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE CADD PUMP HAD A RESIDUAL VOLUME OF ABOUT 88 CC. NO BEEPING WAS REPORTED OVERNIGHT. PUMP WAS PROGRAMMED CORRECTLY. PICC LINE FLUSHED EASILY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14320402 ↗
• MalfunctionMar 3, 2021Insufficient Flow or Under Infusion; Pressure Problem; Insufficient Flow or Under Infusion; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP MIGHT HAVE CONTRIBUTED TO CAUSING AN INFUSION ISSUE AND A HIGH-PRESSURE ERROR. IT WAS ALSO REPORTED THAT WHEN THE TUBING IS USED WITHOUT THE ANTI-SIPHON VALVE IT WORKS FINE. THE PATIENT DID NOT RECEIVE THE ENTIRE AMOUNT OF CHEMOTHERAPY DUE TO THIS ISSUE, BUT THERE WERE NO ADVERSE EVENTS REPORTED. WHEN THE TUBING WAS CHANGED, MEDICATION WAS ADMINISTERED AND COMPLETED AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11407905 ↗
• MalfunctionMar 3, 2021Insufficient Flow or Under Infusion; Pressure Problem; Insufficient Flow or Under Infusion; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP MIGHT HAVE CONTRIBUTED TO CAUSING AN INFUSION ISSUE AND A HIGH-PRESSURE ERROR. IT WAS ALSO REPORTED THAT WHEN THE TUBING IS USED WITHOUT THE ANTI-SIPHON VALVE IT WORKS FINE. THE PATIENT DID NOT RECEIVE THE ENTIRE AMOUNT OF CHEMOTHERAPY DUE TO THIS ISSUE, BUT THERE WERE NO ADVERSE EVENTS REPORTED. WHEN THE TUBING WAS CHANGED, MEDICATION WAS ADMINISTERED AND COMPLETED AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11407858 ↗
• MalfunctionMar 3, 2021Insufficient Flow or Under Infusion; Pressure Problem; Insufficient Flow or Under Infusion; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP MIGHT HAVE CONTRIBUTED TO CAUSING AN INFUSION ISSUE AND A HIGH-PRESSURE ERROR. IT WAS ALSO REPORTED THAT WHEN THE TUBING IS USED WITHOUT THE ANTI-SIPHON VALVE IT WORKS FINE. THE PATIENT DID NOT RECEIVE THE ENTIRE AMOUNT OF CHEMOTHERAPY DUE TO THIS ISSUE, BUT THERE WERE NO ADVERSE EVENTS REPORTED. WHEN THE TUBING WAS CHANGED, MEDICATION WAS ADMINISTERED AND COMPLETED AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11407741 ↗
• MalfunctionMar 3, 2021Insufficient Flow or Under Infusion; Pressure Problem; Insufficient Flow or Under Infusion; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP MIGHT HAVE CONTRIBUTED TO CAUSING AN INFUSION ISSUE AND A HIGH-PRESSURE ERROR. IT WAS ALSO REPORTED THAT WHEN THE TUBING IS USED WITHOUT THE ANTI-SIPHON VALVE IT WORKS FINE. THE PATIENT DID NOT RECEIVE THE ENTIRE AMOUNT OF CHEMOTHERAPY DUE TO THIS ISSUE, BUT THERE WERE NO ADVERSE EVENTS REPORTED. WHEN THE TUBING WAS CHANGED, MEDICATION WAS ADMINISTERED AND COMPLETED AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11407596 ↗
• MalfunctionJan 12, 2021Insufficient Flow or Under Infusion; Improper Flow or Infusion; Insufficient Flow or Under Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT A CUSTOMER FOUND RESIDUAL VOLUME OF 35 MLS WAS LEFT IN THE 250 ML BAG AFTER USING A SMITHS MEDICAL ADMIN SET. THE PUMP STATED 248.3 MLS INFUSED FROM 250 ML BAG. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 11156193 ↗
• MalfunctionNov 24, 2020Inaccurate Delivery; Inaccurate Delivery

  INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT TAZOZIN WAS RUNNING INTERMITTENTLY AT A DOSE OF 159ML/HOUR FOR 8 HOURS WITH A 500 ML BAG. HOWEVER, THERE WAS 54 ML RESIDUAL AT THE END OF INFUSION. NO PATIENT INJURY WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10893103 ↗
• MalfunctionNov 9, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP HAD UNDER INFUSED MEDICATION. THE PROGRAM WAS AS FOLLOWS: 500 MLS OF 13500 MG OF PIPERACILLIN WAS TO BE INFUSED 159 MLS/HOUR. THERE SHOULD HAVE ONLY BEEN 12.4 ML OF THE MEDICATION LEFT AT THE END OF THE INFUSION, HOWEVER THE RESIDUAL VOLUME WAS 60 ML. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10814512 ↗
• MalfunctionSep 3, 2020Insufficient Flow or Under Infusion; Priming Problem; Insufficient Flow or Under Infusion; Priming Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP EXPERIENCED A MALFUNCTION. IT WAS REPORTED THAT WHEN USING THE ADMINISTRATION SET THERE WAS DIFFICULTY EXPERIENCED DURING PRIMING THE PUMP AND THERE WAS ALSO ISSUES WITH UNDER DELIVERY. THE ISSUE OCCURRED DURING TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 10489321 ↗
• MalfunctionSep 3, 2020Insufficient Flow or Under Infusion; Priming Problem; Insufficient Flow or Under Infusion; Priming Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP EXPERIENCED A MALFUNCTION. IT WAS REPORTED THAT WHEN USING THE ADMINISTRATION SET THERE WAS DIFFICULTY EXPERIENCED DURING PRIMING THE PUMP AND THERE WAS ALSO ISSUES WITH UNDER DELIVERY. THE ISSUE OCCURRED DURING TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 10489269 ↗
• MalfunctionSep 3, 2020Insufficient Flow or Under Infusion; Priming Problem; Insufficient Flow or Under Infusion; Priming Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP EXPERIENCED A MALFUNCTION. IT WAS REPORTED THAT WHEN USING THE ADMINISTRATION SET THERE WAS DIFFICULTY EXPERIENCED DURING PRIMING THE PUMP AND THERE WAS ALSO ISSUES WITH UNDER DELIVERY. THE ISSUE OCCURRED DURING TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 10488529 ↗
• MalfunctionSep 3, 2020Insufficient Flow or Under Infusion; Priming Problem; Insufficient Flow or Under Infusion; Priming Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - FLOW STOP EXPERIENCED A MALFUNCTION. IT WAS REPORTED THAT WHEN USING THE ADMINISTRATION SET THERE WAS DIFFICULTY EXPERIENCED DURING PRIMING THE PUMP AND THERE WAS ALSO ISSUES WITH UNDER DELIVERY. THE ISSUE OCCURRED DURING TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 10488397 ↗
• MalfunctionJun 9, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT UNDER DELIVERY OCCURRED WHILE USING THE CADD ADMINISTRATION SET. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134686 ↗
• MalfunctionJun 9, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION WAS RECEIVED INDICATING THAT UNDER DELIVERY OCCURRED WHILE USING THE CADD ADMINISTRATION SET. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134602 ↗

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-0963-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8)
• 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