ICU Medical MC330419Recalls & reported problems
Icu Medical, Inc. · 102" (259 cm) Appx 8.2 ml, PUR Standardbore/Smallbore Transfer Set w/MicroClave™ Clear, Dual Check Valve, 1.2 Micron Filter, Luer Lock · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical smallbore transfer set is a long IV tubing set with a filter and a MicroClave connector, used to transfer fluids and medications. Its 47 reports mostly describe fluid or blood leaking from the tubing, connections, or filter — sometimes lines coming loose and one report of cracked plastic — along with a few cases of no flow and alarms not sounding. No deaths and no injuries are reported. No recalls name this device, and the number of reports is similar to the prior 12 months.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00887709087552), received between Nov 10, 2023 and Jul 17, 2026 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (44 reports).
188 other recalls cover devices cleared under the same FDA submission (K964435); 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
Most reported problems
Device problems
- Fluid/Blood Leak44
- Alarm Not Visible1
- Crack1
- Disconnection1
- Free or Unrestricted Flow1
- Material Split, Cut or Torn1
- No Audible Alarm1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25854865 ↗MalfunctionMar 11, 2026Disconnection
AN EVENT INVOLVING A SMALLBORE TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT AFTER THE BABY WAS RETURNED FROM SKIN-TO-SKIN CARE, STAFF CHECKED ALL THE LINES AND FOUND THAT THE MORPHINE LINE HAD COME LOOSE AND WAS ON THE FLOOR. THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) SITE AND DRESSING WERE STILL SECURE, AND ALL OTHER LINES WERE CONNECTED PROPERLY. THE DISCONNECTED MORPHINE AND TUBING WERE THROWN AWAY. A NEW MORPHINE INFUSION WAS PREPARED AND CONNECTED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24573960 ↗MalfunctionMar 6, 2026Fluid/Blood Leak
AN EVENT INVOLVED A 102" (259 CM) PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK WHERE IT WAS REPORTED THAT DURING THEIR SAFETY CHECK LIPID FLUID FOUND TO BE LEAKING FROM THE CLAVE BETWEEN THE LIPID TUBING AND THE SYRINGE LOADED ON THE MEDICATION PUMP. IT WAS BASED ON THE VISIBLE POOLING OF FLUIDS ON THE PUMP, THE LEAKING SUSPECTED TO BE ONGOING FOR AT LEAST A FEW HOURS. ALL CONNECTIONS WERE TIGHTENED, AND NO VISIBLE CRACKS WERE SEEN, BUT THE FLUID WAS STILL LEAKING. THE NEW TUBING AND SYRINGE WERE HUNG, AND NO LEAKING WAS SEEN AFTER THE CHANGE. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24529603 ↗MalfunctionFeb 23, 2026Crack; Fluid/Blood Leak
AN EVENT INVOLVING A SMALLBORE TRANSFER SET WITH MICROCLAVE CLEAR LUER LOCK REPORTED THAT WHEN TRACING THE PATIENT'S LINES, THEY NOTICED THAT THERE WAS POOLING OF LIPIDS ON THE SYRINGE PUMP. WHEN THEY WENT TO INSPECT THE LINE, THEY NOTICED LIPIDS WERE LEAKING FROM THE CONNECTION PIECE BETWEEN THE SYRINGE AND THE TUBING AND IT LOOKED LIKE THE END PIECE THAT GOES INTO THE SYRINGE WAS CRACKED. THEY STOPPED INFUSION AND SWITCHED OUT THE TUBING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24412561 ↗MalfunctionFeb 20, 2026Fluid/Blood Leak
CLARIFICATION WAS RECEIVED STATING THAT THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403180 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak
A SECOND USED SAMPLE WAS RETURNED FOR INVESTIGATION. THIS EMDR REFLECTS THE SECOND TESTING FAILURE FOR THE SECOND SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264609 ↗MalfunctionFeb 2, 2026Fluid/Blood Leak
A MORPHINE INFUSION LINE RUNNING AT 0.2ML/H WAS REPORTEDLY LEAKING ABOVE THE FILTER AT THE HARD PLASTIC CONNECTION PIECE OF THE FOLLOWING DEVICE: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK, BELOW A SYRINGE. THIS ISSUE CAUSED UNEXPECTED OR PROLONGED (UNSPECIFIED) CARE; HOWEVER, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24238446 ↗MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK AND IT WAS REPORTED THAT THE FILTER WAS LEAKING AT LESS THAN TWO DAYS OF USE, RATE OF INFUSION WHICH IS 1ML/H. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812952 ↗MalfunctionDec 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
AN EVENT INVOLVED A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT THE AADS (AMINO ACID PLUS DEXTROSE SOLUTION) FILTER WAS LEAKING ON STANDARD CONCENTRATION TUBING. ADDITIONALLY, A REGISTERED NURSE NOTICED WHEN PUMP RINGING "HIGH PRESSURE". THE WRITER HAD JUST CHANGED SYRINGE BEFORE LEAVING POD FOR BREAK. WHILE TRACING LINES, NOTED THE LEAKING AND CHANGED THE TUBING. THIS CAUSES UNEXPECTED OR PROLONGED CARE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799921 ↗MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE. IT WAS REPORTED THAT THERE WAS A HIGH FAILURE RATE OF THE FILTER SETS LEAKING, FOR BOTH THE OLD DESIGN AND THE NEW DESIGN SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764793 ↗MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE FILTER LEAKING FROM AADS (ADDED AMINO ACIDS DEXTROSE SOLUTION) INFUSION LINE. THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739218 ↗MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK AND IT WAS REPORTED THAT THE TRANSFER SET WAS INFUSING PARENTERAL NUTRITION LEAKING FROM RECTANGLE 1.2-MICRON FILTER. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739179 ↗MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
AN EVENT INVOLVED A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT TPN (TOTAL PARENTAL NUTRITION PLUS LIPIDS) WAS RUNNING THROUGH THE AADS (AMINO ACIDS PLUS DEXTROSE SOLUTION) LINE AND THE FILTER LEAKED AT FILTER CLOSEST TO THE BAG. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23712640 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK. IT WAS REPORTED THAT THE IN-LINE FILTER WAS FOUND LEAKING AT SHIFT ONSET. A SYRINGE PUMP/MICROBORE TUBING USED FOR AADS INFUSION WAS USED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707717 ↗MalfunctionNov 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK. IT WAS REPORTED THAT THE SMOF WAS RUNNING THROUGH THE INLINE MICRO FILTER STANDARDIZED TUBING AND FELT STICKINESS AT THE HUB OF THE T PART WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663285 ↗MalfunctionNov 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23628063 ↗MalfunctionNov 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A 102" (259 CM) PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT THE IN-LINE FILTER ON THE SYRINGE PUMP TUBING FOUND LEAKING AT SHIFT ONSET. LINE INFUSING AADS (AMINO ACID PLUS DEXTROSE SOLUTION), LINE WAS CHANGED ONE DAY PRIOR. AADS INFUSION HAD TO BE STOPPED AND REPLACED WITH MAINTENANCE INFUSION, ON A PATIENT WITH CRITICALLY LOW BLOOD GLUCOSE LEVELS ONE DAY PRIOR. THESE FILTERS ALWAYS LEAK PRIOR TO THE 96-HOUR EXPIRY OF THE LINE, WHEN INFUSING AADS. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602424 ↗MalfunctionNov 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT AADS (AMINO ACID PLUS DEXTROSE SOLUTION) INFUSION INFUSING VIA SYRINGE PUMP. IN-LINE FILTER FOUND LEAKING AT SHIFT ONSET. AADS INFUSION STOPPED, MAINTENANCE INFUSION CHANGED. WHEN INFUSING AADS OVER SYRINGE PUMP, THE LINE SHOULD BE CHANGED Q24H INSTEAD OF Q96H. THE FILTER NEVER LASTS 96 HOURS WITHOUT LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602352 ↗MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
A COMPLAINT WAS RECEIVED REGARDING 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK THAT EXPERIENCED LEAKAGE DURING USE. IT WAS REPORTED THAT PATIENT'S PUMP RINGING OCCLUDED; NURSE TRACED LINE TO ENSURE NO CLAMPS ENGAGED, NO KINKS ALONG LINE, AND FLUSHED LINE TO ENSURE PATENCY. NURSE CALLED THE CHARGE NURSE TO COME INSPECT AT BEDSIDE AND EVENTUALLY DISCOVERED THE FILTER OF THE PRIMARY TUBING LEAKING NEONATAL 2-IN-1 COMPOUND. THE DOCTOR WAS NOTIFIED AND REPLACEMENT FLUIDS ORDER AND A LINE CHANGE OCCURRED. THERE WAS NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535721 ↗MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
AN INCIDENT INVOLVING 102" (259 CM) PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK. IT WAS REPORTED THAT THE SMOF TUBING WAS FOUND TO BE LEAKING AT THE JUNCTION WHERE THE STRAIGHT TUBING IS CONNECTED TO THE LUER LOCK CONNECTION. SMOF WAS NOTED TO BE LEAKING INTO LINENS AND WAS NOT BEING DELIVERED TO PATIENT. UPON REMOVAL OF THE TUBING AND MANUAL ADMINISTRATION USING A SYRINGE, THE LEAKAGE COULD BE REPRODUCED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS DELAY IN THERAPY, BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23529480 ↗MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
EVENT OCCURRED WITH REGARDS TO A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK WHERE THE REPORTER STATED THAT "WHEN TRACING LINES AT SHIFT ONSET THE SYRINGE PUMP TUBING INFUSING ANTIARRHYTHMIC DRUGS (AADS) WAS FOUND TO BE LEAKING VIA THE IN-LINE FILTER. AS A RESULT, THE AADS INFUSION NEEDED TO BE DISCONTINUED AND DISCARDED. PATIENT'S MAINTENANCE INFUSION CHANGED." THEY ALSO REPORTED THAT THE PATIENT'S LINES ARE MEANT TO BE CHANGED EVERY 96 HOURS, AND THIS LEAK WAS FOUND ON DAY 3. PROCEDURE WAS ANTIARRHYTHMIC DRUGS (AADS) INFUSION VIA PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069388 ↗MalfunctionSep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
EVENT OCCURRED REGARDING 102" (259 CM) PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK WHERE THE REPORT STATED THAT "THEY NOTICED FILTER ON STANDARD CONCENTRATION TUBING FOR AUTOMATED DRUG DISPENSING SYSTEM (AADS) LEAKING/STICKY, AND THEY CHANGED OUT FOR NEW TUBING." THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22971938 ↗MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
EVENT OCCURRED REGARDING 102" (259 CM) PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK WHERE IT WAS REPORTED THAT THE AADS LINE AND 3-WAY CONNECTOR WERE FOUND TO BE LEAKING. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873886 ↗MalfunctionAug 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
EVENT OCCURRED INVOLVING A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK. IT WAS REPORTED THAT THE SYRINGE PUMP SET WAS LEAKING SMOF AT THE VALVE BY THE 3-WAY CONNECTOR. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WERE NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22861613 ↗MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE FILTER OF A 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK WAS REPORTEDLY STICKY AND LEAKING. AMINO ACIDS AND DEXTROSE SOLUTION (AADS) WAS INFUSING AT THE TIME AND THIS PROBLEM WAS DISCOVERED UPON THE START OF SHIFT, WHEN SAFETY CHECKS AND LINE TRACING WERE COMPLETED. NNP NOTED AND NEW FLUIDS ORDERED. FULL LINE CHANGE COMPLETED. THERE WAS NO SERIOUS HARM OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22714394 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.
- Z-3163-2026 · May 12, 2026 · Open, ClassifiedIV Sets with drip chambers
- Z-3157-2026 · May 12, 2026 · Open, ClassifiedIV Non-Dedicated Gravity Administration Sets with drip chambers
- Z-0154-2026 · Oct 2, 2025 · Open, ClassifiedIV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
- Z-1721-2022 · Aug 1, 2022 · Open, Classified6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
- Z-0956-2021 · Dec 2, 2020 · Terminated60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
- Z-0958-2021 · Dec 2, 2020 · Terminated154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
- Z-0957-2021 · Dec 2, 2020 · Terminated7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
- Z-0955-2021 · Dec 2, 2020 · Terminated60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
- Z-0217-2021 · Jul 6, 2020 · TerminatedAppx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)
- Z-0211-2021 · Jul 6, 2020 · Terminated5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)
- Z-0224-2021 · Jul 6, 2020 · Terminated3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50
- Z-0216-2021 · Jul 6, 2020 · Terminated54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
- Z-0227-2021 · Jul 6, 2020 · Terminated142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
- Z-0262-2021 · Jul 6, 2020 · Terminated8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron i
- Z-0183-2021 · Jul 6, 2020 · Terminated6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)
…and 173 more.
Other Stopcock, i.V. Set devices
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- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 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
- 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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