ICU Medical 011-C3302Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00840619001537), received between Mar 15, 2022 and Sep 17, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  The event involved a Smallbore Ext Set with MicroClave. It was reported that there was leakage from the clave. The issue was noted during priming. There were no concomitant drug and concomitant device involved. There was no bleedback, no biohazard, no user facility MedWatch, and no chemo. The device was not reprocessed or resterilized. The quantity affected is 2, and the sample is available for return.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805603 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652670 ↗
• MalfunctionJun 9, 2026Fluid/Blood Leak

  AN EVENT INVOLVED AN EXT SET, SMALLBORE WITH CLAVE WHERE IT WAS REPORTED THAT LEAKAGE FROM CLAVE AND THE TUBE JUNCTION DURING INFUSION. THERE WAS NO BLEED BACK REPORTED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441730 ↗
• MalfunctionJun 18, 2025Particulates; Particulates

  THE COMPLAINT INVOLVED A EXT SET, SMALLBORE WITH CLAVE¿. IT WAS REPORTED THAT THERE WAS BLACK CONTAMINATION FOUND ON THE FRONT PART OF THE PRODUCT TUBING. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282707 ↗
• MalfunctionDec 13, 2024Separation Problem; Separation Problem

  THE EVENT INVOLVED AN EXT SET, SMALLBORE WITH CLAVE WHERE IT WAS REPORTED THERE WERE TWO EVENTS THAT THE TUBING POPS OFF. THE EVENT OCCURRED DURING BLOOD TRANSFUSION. THE DEVICE WAS REPLACED TWICE, THEN THE BLOOD TRANSFUSION RESUMED. DEVICE WAS NOT REPROCESSED/ RE STERILIZED. THE USER DID NOT RECORD ANY HOLES, CUTS, TEARS, OR DEFECTS. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925408 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A EXT SET, SMALLBORE WITH CLAVE WHERE IT WAS THE SILICONE CLAVE WAS SUNKEN AND LEAKED FROM CLAVE. THERE WAS LEAKAGE AT THE DRIP CHAMBER. THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM. THE CONCOMITANT DRUG USED WAS AN ANTIBIOTIC. THE EVENT OCCURRED DURING INFUSION. DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921706 ↗
• MalfunctionOct 11, 2024Disconnection; Disconnection

  THE COMPLAINT/EVENT INVOLVED A EXT SET, SMALLBORE WITH CLAVE¿. IT WAS REPORTED THAT THE DEVICE DOES NOT CONNECT TIGHTLY AND THE TUBING POPPED OFF DURING A PATIENT'S INFUSION OF AN UNSPECIFIED INFUSATE; HOWEVER, THERE WAS NO MEDICATION INVOLVED. THERE WAS NO CONCOMITANT DRUG AND NO CONCOMITANT DEVICE. THERE WAS NO SPECIFIC PHYSICAL DAMAGE NOTED ON THE SET. THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM. THERE WAS NO LEAKAGE, NO ANY UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL, NO INTERVENTIONS DONE DUE TO SPILLAGE, NO CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL, AND NO SPILL KIT USED. THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM. THERE WAS NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434375 ↗
• MalfunctionSep 9, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT TWO 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER WERE FOUND NOT TO CONNECT DURING PATIENT USE. THE REPORTER STATED, "IT DOESN'T CONNECT TIGHTLY; THE TUBING POPS OFF." THE EVENT OCCURRED DURING INFUSION. THERE WAS NO CONCOMITANT DRUG AND NO CONCOMITANT DEVICE. THERE WAS NO BLEEDBACK, NO BIOHAZARD, NO CHEMO, AND UNKNOWN USER FACILITY MEDWATCH. THE SAMPLE IS AVAILABLE FOR RETURN. THERE WAS NO PICTURE PROVIDED. THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THERE WERE NO PHYSICAL DEFECTS NOTED ON THE PRODUCT, BUT ONE TUBE WAS BROKEN WHEN THEY RECEIVED THEM. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20172769 ↗
• MalfunctionAug 27, 2024Disconnection; Disconnection

  THE EVENT INVOLVED A EXT SET, SMALLBORE WITH CLAVE¿ WHERE IT WAS REPORTED THAT THE DEVICE DOESN'T ONNECT TIGHTLY; THE TUBING POPS OFF.THE EVENT OCCURRED DURING INFUSION. THERE WAS NO CONCOMITANT DRUG WITH NO CONCOMITANT DEVICE INVOLVED. THERE WAS NO BLEEDBACK, NO CHEMO, NO BIOHAZARD AND UNKNOWN USER FACILITY MEDWATCH. DEVICE WAS NOT REPROCESSED/RESTERILIZED . THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/ PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077573 ↗
• MalfunctionJul 6, 2024No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED EXT SET, SMALLBORE WITH CLAVE¿ WAS FOUND TO HAVE EXPERIENCED A NO-FLOW EVENT DURING PATIENT USE. THE REPORTER STATED, ¿THERE IS RESISTANCE DURING INJECTION, MAKING IT DIFFICULT TO PUSH." THE EVENT OCCURRED DURING INFUSION. IT WAS ALSO MENTIONED THAT THERE WAS NO CONCOMITANT DRUG, NO CONCOMITANT DEVICE, NO BLEED-BACK, NO CHEMO DRUG, NO BIO-HAZARD, AND AN UNKNOWN USER FACILITY MED-WATCH. THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THE QUANTITY AFFECTED IS 1 AND IS AVAILABLE FOR RETURN FOR EVALUATION. THE SAMPLE WAS RETURNED FROM CLINICAL CONTACT. A SAMPLE PHOTO IS NOT PROVIDED. AN EVALUATION LETTER IS REQUESTED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM, AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19685141 ↗
• MalfunctionJul 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER. RESISTENCE WAS REPORTED DURING INJECTION, MAKING IT DIFFICULT TO PUSH DURING PATIENT INFUSION. THERE WAS NO BLEED BACK, NO CHEMOTHERAPY INVOLVED, AND NO PHYSICAL DAMAGE NOTED ON THE DEVICE. THE TUBING WAS REPLACED, AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY AS A RESULT OF THE COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643280 ↗
• MalfunctionJun 18, 2024No Flow; No Flow

  THE EVENT INVOLVED AN EXTENSION SET, SMALLBORE WITH CLAVE¿ WHERE IT WAS REPORTED THAT THERE WAS NO FLOW. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT OR PATIENT HARM. THE REPORTER STATED, ¿AFTER CONNECTING TO THE PATIENT'S END, THE IV DRIP CANNOT RUN AT FULL SPEED. WE HAVE ALREADY RECONNECTED THE IV AND REPLACED THE T-CONNECTOR.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562757 ↗
• MalfunctionApr 11, 2024No Flow; No Flow

  THE COMPLAINT/EVENT INVOLVED A EXT SET, SMALLBORE WITH CLAVE¿. IT WAS REPORTED THAT THE SOLUTION COULD NOT DRIP DURING A PATIENT'S INFUSION. THERE WAS NO CONCOMITANT DRUG AND NO CONCOMITANT DEVICE INVOLVED. THERE WAS NO BLEED BACK OR BIOHAZARD. THERE WAS NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093684 ↗
• MalfunctionOct 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A EXT SET, SMALLBORE WITH CLAVE¿ WHERE IT WAS REPORTED THE SYRINGE IS HARD TO CONNECT TO CLAVE, AND NORMAL SALINE LEAKED FROM THE CLAVE. THE EVENT OCCURRED DURING INFUSION. THERE WAS NO CONCOMITANT DRUG AND NO CONCOMITANT DEVICE INVOLVED. THERE WAS NO BLEED BACK NOTED. THE DEVICE WAS NOT USED FOR CHEMO AND IT IS NOT A BIO-HAZARD. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013044 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED EXT SET, SMALLBORE WITH CLAVE IN WHICH THE CUSTOMER REPORTED THAT THE SOLUTION LEAKED FROM THE BLUE SITE DURING INFUSION OF NORMAL SALINE. THERE WAS NO BLEED BACK AND THE DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE WAS NO PHYSICAL DAMAGED NOTED ON THE DEVICE. THE SET WAS REPLACED AND THERAPY RESUMED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493444 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W / MICROCLAVE® CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 12 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243323 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 5 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243307 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 4 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243296 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 8 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243274 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  HOLD NW. THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 11 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243026 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 10 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243013 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 9 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242978 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 7 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242971 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 6 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242952 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER STATED THAT THE DEVICE CANNOT CONNECT TIGHTLY AND CAUSING LEAKAGE. THE DEVICE WAS REPORTED TO BE USED FOR NORMAL INFUSION THERAPY ON A PATIENT IN WARD 5. THERE WERE NO HOLES, CUTS, CRACKS, TEARS OR DEFECTS NOTED. THERE WAS NO BLEEDBACK, NO BIOHAZARD AND NO CHEMO USED. THE CLINICAL STAFF CHANGED THE TUBING AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT/PATIENT HARM OR DELAY IN THERAPY REPORTED. THIS IS REPORT 3 OF 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242839 ↗

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-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV 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, Classified
  6.5" (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 · Terminated
  60" (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-0957-2021 · Dec 2, 2020 · Terminated
  7 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-0958-2021 · Dec 2, 2020 · Terminated
  154 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-0955-2021 · Dec 2, 2020 · Terminated
  60 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-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• Z-0222-2021 · Jul 6, 2020 · Terminated
  123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The In
• Z-0242-2021 · Jul 6, 2020 · Terminated
  11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(
• Z-0231-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)1088770908
• Z-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I

…and 173 more.