CADD 21-7001-24Recalls & 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 infusion pump is used to deliver medication. Most of the 100 reports mention malfunctions, mainly fluid leaks, electrical issues, missing or wrong markings, and connection problems; there were no deaths or injuries. Two recalls are open; both started in August 2025 and June 2024 and involve weakened welds that could let medication leak from cassette reservoirs.
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
- 100
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 10610586022111), received between Mar 21, 2018 and Jul 15, 2026 — classified as 100 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (24 reports).
2 FDA recall records name this device's identifier, 2 still open.
12 other recalls cover devices cleared under the same FDA submission (K843772); 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.
Reports received per month
Recalls naming this device
- Aug 6, 2025Class IIOpen, Classified
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Z-2522-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 26, 2024Class IIOpen, Classified
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Z-0014-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Electrical /Electronic Property Problem24
- Fluid/Blood Leak22
- Device Markings/Labelling Problem17
- Connection Problem15
- Deformation Due to Compressive Stress7
- Device Alarm System3
- Device Sensing Problem3
- Failure to Infuse2
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Consequences Or Impact To Patient13
- No Known Impact Or Consequence To Patient6
- No Information2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25833679 ↗MalfunctionJul 15, 2026Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE WAS OBSERVED FROM TWO INFUSION SETS FOLLOWING DELIVERY TO THE PATIENT. THE LIQUID WAS REPORTED TO BE LEAKING FROM THE POINT WHERE THE TUBING ENTERED THE INNER CASING APPROXIMATELY ONE HOUR AFTER CANNULA INSERTION. THERE WAS PATIENT INVOLVEMENT WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25833582 ↗MalfunctionJan 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE POUCH WAS NOT AIRTIGHT WHEN THE CUSTOMER PUTS THE LIQUID IN IT. THERE WAS A FLOW. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23961140 ↗MalfunctionAug 5, 2025Excess Flow or Over-Infusion; Inaccurate Delivery; Excess Flow or Over-Infusion; Inaccurate Delivery
IT WAS REPORTED THAT THE TOTAL VOLUME WAS 153 ML. THE PUMP FINISHED 8 HOURS EARLY SAYING THERE WAS STILL 53 ML IN CASSETTE. THE CASSETTE WAS EMPTY. THE AMOUNT OF MEDICATION REMAINING IN CASSETTE/BAG DID NOT MATCH THE RESERVOIR VOLUME DISPLAYED ON PUMP. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22714218 ↗MalfunctionJan 24, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT DURING INFUSION THE DEVICE FOR NO APPARENT REASON STARTED TO ALARM ¿CASSETTE IS NOT SET CORRECTLY¿. PER REPORTER, THIS HAPPENED ON 3-9 OCCASIONS. THE EXACT DATES ARE UNKNOWN, BUT THEY HAVE HAPPENED IN A TIME PERIOD OF (B)(6) 2024. THE DEVICE WAS CHECKED SEVERAL TIMES BY A BIOMEDIC AND PASSED THE ANNUAL CHECK WELL. POSSIBLE LOT NUMBER PROVIDED:43491. THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233480 ↗MalfunctionJan 24, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT DURING INFUSION THE DEVICE FOR NO APPARENT REASON STARTED TO ALARM ¿CASSETTE IS NOT SET CORRECTLY¿. PER REPORTER, THIS HAPPENED BETWEEN 3-9 OCCASIONS. THE EXACT DATES ARE UNKNOWN, BUT THEY HAVE HAPPENED IN A TIME PERIOD OF (B)(6) 2024. THE DEVICE WAS CHECKED SEVERAL TIMES BY A BIOMEDIC AND PASSED THE ANNUAL CHECK WELL. POSSIBLE LOT NUMBER PROVIDED:435422. THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232981 ↗MalfunctionJan 24, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT DURING INFUSION THE DEVICE FOR NO APPARENT REASON STARTED TO ALARM ¿CASSETTE IS NOT SET CORRECTLY¿. PER REPORTER, THIS HAPPENED ON 3-9 OCCASIONS. THE EXACT DATES ARE UNKNOWN, BUT THEY HAVE HAPPENED IN A TIME PERIOD OF APRIL ¿ DECEMBER 2024. THE DEVICE WAS CHECKED SEVERAL TIMES BY A BIOMEDIC AND PASSED THE ANNUAL CHECK WELL. POSSIBLE LOT NUMBER PROVIDED: 439099. THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232963 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208710 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208571 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
UPDATE: GCM RECEIVED AN EMAIL ON 20-AUG-2024 FROM (B)(6), FROM FACILITY (B)(6), STATING THAT THEY DISCOVERED THAT A NUMBER OF CADD MEDICATION CASSETTES HAD A PACKAGING FAULT, ITEM 21-7002-24 HAD A DIFFERENT IFU INSERTED WITHIN THE SEALED PACKAGING FOR ITEM 21-7301-24 CADD CASSETTE 50ML FLOW STOP. THE ACTUAL PRODUCT INSIDE WAS ITEM 21-7002-24. THE DEVICE IS AVAILABLE FOR INVESTIGATION. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. ALL STOCK WAS CHECKED AND AFFECTED STOCK WAS QUARANTINED. NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT HARM. PMITROFAN (B)(6) 2024. UPDATE: IN CLARIFICATION TO THE ABOVE DOCUMENTATION, THE PACKAGING FAULT FOR THE PRODUCT WITH ITEM NUMBER 21-7001-24 AND LOT NUMBER 4349110 WAS NOT SPECIFIED BY THE CUSTOMER USING DIFFERENT ITEM NUMBERS. THE ERROR DESCRIBED ABOUT THE PRODUCT WITH A DIFFERENT ITEM NUMBER APPLIES TO THE REFERENCED ASSOCIATED COMPLAINT. PMITROFAN (B)(6)2024. UPDATE: IN CLARIFICATION TO THE ABOVE DOCUMENTATION, GCM RECEIVED AN EMAIL ON 20-AUG-2024 FROM (B)(6), FROM FACILITY (B)(6), STATING THAT THEY DISCOVERED THAT A NUMBER OF CADD MEDICATION CASSETTES HAD A PACKAGING FAULT. PMITROFAN (B)(6
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208502 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208397 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207984 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207848 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207570 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207399 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207379 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207093 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206995 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206980 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206845 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206753 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206344 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206171 ↗MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE 17 PACKS AND 4 CASSETTES IN EACH PACKAGE WHERE THERE WAS A PACKAGING ERROR. THE SITE DISCOVERED THAT A NUMBER OF CASSETTES HAD A PACKAGING FAULT, WHERE A DIFFERENT INSTRUCTION FOR USE (IFU) DOCUMENT WAS INSERTED WITHIN THE SEALED PACKAGING FOR A DIFFERENT ITEM NUMBER OF A DIFFERENT CASSETTE PRODUCT. THE ISSUE WAS DISCOVERED AFTER SOME OF THE SAMPLES WERE POTENTIALLY SENT OUT TO PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206077 ↗MalfunctionMay 13, 2024Particulates; Particulates
IT WAS REPORTED THAT: ¿THE PHARMACIST FOUND A CASSETTE, THAT HAD BLUE (PLASTIC?) PARTICLES INSIDE IT, BEFORE FILLING THE CASSETTE¿. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19304311 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K843772. One submission often covers many models, so check the product and lot details in each record.
- Z-0062-2018 · Sep 25, 2017 · TerminatedCADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CA
- Z-0060-2018 · Sep 25, 2017 · TerminatedCADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(
- Z-0061-2018 · Sep 25, 2017 · TerminatedCADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-T
- Z-3071-2017 · Jun 5, 2017 · TerminatedCADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
- Z-1286-2015 · Feb 2, 2015 · TerminatedCADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
- Z-0987-2009 · Dec 9, 2008 · TerminatedCADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for u
- Z-0876-2008 · Dec 14, 2007 · TerminatedSmiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
- Z-0878-2008 · Dec 14, 2007 · TerminatedSmiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 551
- Z-0877-2008 · Dec 14, 2007 · TerminatedSmiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24 , Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
- Z-1213-2007 · Jun 18, 2007 · TerminatedSmiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical
- Z-1214-2007 · Jun 18, 2007 · TerminatedSmiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC 4694-24A, REF 21-7001-24, Sterile, Made in Mexico Smith Medical MD, In
- Z-1215-2007 · Jun 18, 2007 · TerminatedSmiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
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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