K-Zero® Needleless ConnectorRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04250273735949), received between Dec 2, 2025 and Sep 4, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break; Leak/Splash; No Apparent Adverse Event

  Cases of detachment/fracture between the transparent and coloured components of the check valve have been reported, resulting in blood leakage due to backflow or leakage of the intravenous therapy being administered. Furthermore, several samples were found to be occluded and unusable upon opening of the primary packaging.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603297 ↗
• MalfunctionSep 4, 2026Break; Leak/Splash; No Apparent Adverse Event

  Cases of detachment/fracture between the transparent and coloured components of the check valve have been reported, resulting in blood leakage due to backflow or leakage of the intravenous therapy being administered. Furthermore, several samples were found to be occluded and unusable upon opening of the primary packaging.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603296 ↗
• MalfunctionSep 4, 2026Break; Leak/Splash; No Apparent Adverse Event

  Cases of detachment/fracture between the transparent and coloured components of the check valve have been reported, resulting in blood leakage due to backflow or leakage of the intravenous therapy being administered. Furthermore, several samples were found to be occluded and unusable upon opening of the primary packaging.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603291 ↗
• MalfunctionMar 20, 2026Blocked Connection

  THE FOLLOWING HAS BEEN REPORTED: IT WAS OBSERVED THAT THE DEVICE SHOWS RESISTANCE DURING FLUSHING AND/OR DURING THE COLLECTION OF SAMPLES FOR LABORATORY TESTS (BLOOD). DUE TO THIS NONCONFORMITY, IT HAS BEEN NECESSARY TO REMOVE THE DEVICE IN ORDER TO PERFORM BOTH THE FLUSHING AND THE SAMPLE COLLECTION. THIS SITUATION SIGNIFICANTLY INCREASES THE RISK OF BLOODSTREAM INFECTION DUE TO THE ADDITIONAL MANIPULATION OF THE ACCESS, THEREBY COMPROMISING PATIENT SAFETY. FRESENIUS KABI INVESTIGATION RESULTS AS FOLLOWS: REPORTED COMPLAINT: FLUID INGRESS IN NEEDLE FREE PORT. QUANTITY OF THE SAMPLE(S): NO COMPLAINT SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION. CONCERNED PRODUCT CODE/BATCH: K-ZERO NEEDLELESS CONNECTOR - M79400849Y/32442575. INVESTIGATION REPORT: WE HAVE NOT RECEIVED A COMPLAINT SAMPLE OR PHOTO FOR INVESTIGATION. BASED ON THE REASON FOR THE COMPLAINT, WE PERFORMED A VISUAL INSPECTION OF ALL RETAIN SAMPLES AND DO NOT SEE ANY DEFECTS. THE SETS ARE COMPLETE AND FREE FROM CONTAMINATION. IN THE NEXT STEP, WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND THE RESULTS WERE CORRECT. ADDITIONALLY, WE CONDUCTED A PRACTICAL TEST USING A SYRINGE AND WATER. WE DIDN'T SEE ANY WATER RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651361 ↗
• MalfunctionMar 20, 2026Blocked Connection

  THE FOLLOWING HAS BEEN REPORTED: IT WAS OBSERVED THAT THE DEVICE SHOWS RESISTANCE DURING FLUSHING AND/OR DURING THE COLLECTION OF SAMPLES FOR LABORATORY TESTS (BLOOD). DUE TO THIS NONCONFORMITY, IT HAS BEEN NECESSARY TO REMOVE THE DEVICE IN ORDER TO PERFORM BOTH THE FLUSHING AND THE SAMPLE COLLECTION. THIS SITUATION SIGNIFICANTLY INCREASES THE RISK OF BLOODSTREAM INFECTION DUE TO THE ADDITIONAL MANIPULATION OF THE ACCESS, THEREBY COMPROMISING PATIENT SAFETY. FRESENIUS KABI INVESTIGATION RESULTS AS FOLLOWS: 1. REPORTED COMPLAINT FLUID INGRESS IN NEEDLE FREE PORT 2. QUANTITY OF THE SAMPLE(S) NO COMPLAINT SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION 3. CONCERNED PRODUCT CODE/BATCH K-ZERO NEEDLELESS CONNECTOR - M79400849Y / (B)(6) 4. INVESTIGATION REPORT WE HAVE NOT RECEIVED A COMPLAINT SAMPLE OR PHOTO FOR INVESTIGATION. BASED ON THE REASON FOR THE COMPLAINT, WE PERFORMED A VISUAL INSPECTION OF ALL RETAIN SAMPLES AND DO NOT SEE ANY DEFECTS. THE SETS ARE COMPLETE AND FREE FROM CONTAMINATION. IN THE NEXT STEP, WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND THE RESULTS WERE CORRECT. ADDITIONALLY, WE CONDUCTED A PRACTICAL TEST USING A SYRINGE AND WATER. WE DIDN'T SEE ANY WATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651360 ↗
• MalfunctionMar 20, 2026Device Contamination with Body Fluid

  THE FOLLOWING HAS BEEN REPORTED: DURING MANIPULATION OF THE KEY DEVICE DURING TEST COLLECTION OR MEDICATION ADMINISTRATION, THE NURSING TEAM OBSERVED DIFFICULTY IN WASHING THE DEVICE, WITH BLOOD ACCUMULATION EVEN AFTER NUMEROUS WASHES, CHANGES IN THE CALIBRE OF THE SYRINGES, AND THE WHIRLING METHOD. FRESENIUS KABI INVESTIGATION RESULTS AS FOLLOWS: 1. REPORTED COMPLAINT FLUID INGRESS IN NEEDLE FREE PORT 2. QUANTITY OF THE SAMPLE(S) NO COMPLAINT SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION 3. CONCERNED PRODUCT CODE/BATCH K-ZERO NEEDLELESS CONNECTOR - M79400849Y / (B)(6) 4. INVESTIGATION REPORT WE HAVE NOT RECEIVED A COMPLAINT SAMPLE OR PHOTO FOR INVESTIGATION. BASED ON THE REASON FOR THE COMPLAINT, WE PERFORMED A VISUAL INSPECTION OF ALL RETAIN SAMPLES AND DO NOT SEE ANY DEFECTS. THE SETS ARE COMPLETE AND FREE FROM CONTAMINATION. IN THE NEXT STEP, WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND THE RESULTS WERE CORRECT. ADDITIONALLY, WE CONDUCTED A PRACTICAL TEST USING A SYRINGE AND WATER. WE DIDN'T SEE ANY WATER RESIDUE INSIDE THE K-ZERO. BATCH DOCUMENTATION REVIEW WAS PERFORMED AND FOLLOWING DATA WAS CHECKED: PRODUCTION ORDERS, IN PROCESS CONTROL AND FINAL INSPECTION R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651359 ↗
• MalfunctionDec 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: PER EMAIL FROM THE FRESENIUS KABI SALES DEVELOPMENT REPRESENTATIVE SOUTHEAST ON 11/7/2025: "I HAVE HAD A FEW COMPLAINTS COME FROM OUR CUSTOMER (B)(6) HOSPITAL, REGARDING THE K-ZERO NEEDLESS CONNECTORS "POPPING OFF" AND NOT SECURING ONTO NON-DEDICATED SETS. THIS HAPPENED DURING PATIENT CARE AND CONCERNED THE HOSPITAL, NURSES, PATIENT, ETC. PER PREVIOUS ORDER HISTORY FROM THIS CUSTOMER, THE K-ZERO CONNECTOR THEY ORDER IS THE (B)(4) CONNECTOR." NO ADVERSE EVENTS REPORTED NO SAMPLE AVAILABLE NO PICTURE AVAILABLE. 1. REPORTED COMPLAINT PROBLEMS WITH MEDICATION PORT 2. QUANTITY OF SAMPLE(S) WE DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION 3. CONCERNED PRODUCT CODE / BATCH K-ZERO NEEDLELESS CONNECTOR, (M79400849), UNKNOWN 4. INVESTIGATION REPORT WE HAVE NOT RECEIVED A COMPLAINT SAMPLE FOR INVESTIGATION. AS WE DID NOT RECEIVE THE BATCH NUMBER, AN INSPECTION OF RETAINED SAMPLES AND REVIEW OF BATCH DOCUMENTATION WAS NOT POSSIBLE. WITHOUT FAULTY SAMPLE AND BATCH NUMBER, A MORE DETAILED INVESTIGATION WAS NOT POSSIBLE. IN THE LAST 12 MONTHS (FROM 20.11.2024 TO 19.11.2025) WE HAVE RECEIVED 2 COMPLAINTS FOR THIS ARTICLE WITH THE SAME REASON AS "PROBLEMS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722354 ↗
• MalfunctionDec 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: PER EMAIL FROM THE FRESENIUS KABI SALES DEVELOPMENT REPRESENTATIVE SOUTHEAST ON 11/7/2025: "I HAVE HAD A FEW COMPLAINTS COME FROM OUR CUSTOMER (B)(6) HOSPITAL, REGARDING THE K-ZERO NEEDLESS CONNECTORS "POPPING OFF" AND NOT SECURING ONTO NON-DEDICATED SETS. THIS HAPPENED DURING PATIENT CARE AND CONCERNED THE HOSPITAL, NURSES, PATIENT, ETC. PER PREVIOUS ORDER HISTORY FROM THIS CUSTOMER, THE K-ZERO CONNECTOR THEY ORDER IS THE M79400849 CONNECTOR." NO ADVERSE EVENTS REPORTED. NO SAMPLE AVAILABLE. NO PICTURE AVAILABLE. 1. REPORTED COMPLAINT: PROBLEMS WITH MEDICATION PORT. 2. QUANTITY OF SAMPLE(S): WE DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION. 3. CONCERNED PRODUCT CODE / BATCH: K-ZERO NEEDLELESS CONNECTOR, (M79400849), UNKNOWN. 4. INVESTIGATION REPORT: WE HAVE NOT RECEIVED A COMPLAINT SAMPLE FOR INVESTIGATION. AS WE DID NOT RECEIVE THE BATCH NUMBER, AN INSPECTION OF RETAINED SAMPLES AND REVIEW OF BATCH DOCUMENTATION WAS NOT POSSIBLE. WITHOUT FAULTY SAMPLE AND BATCH NUMBER, A MORE DETAILED INVESTIGATION WAS NOT POSSIBLE. IN THE LAST 12 MONTHS (FROM 20.11.2024 TO 19.11.2025) WE HAVE RECEIVED 2 COMPLAINTS FOR THIS ARTICLE WITH THE SAME REASON A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722293 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: ON 11/3/2025 FENWAL INTERNATIONAL QE COMPLAINTS ENGINEER RECEIVED A [FRESENIUS KABI] IVENIX COMPLAINT/DISPOSABLE FOR EVALUATION AND DURING EVALUATION THEY FOUND A DEFECT WITH A BLONIE PRODUCT. NO ADVERSE EVENT REPORTED. NO SAMPLE AVAILABLE. PICTURES AVAILABLE. FINDING: DURING SAMPLE EVALUATION THE CAP WAS FOUND TO BE SEPARATED FROM Y-PORT. CRACKED CAP. NOTE: THIS WAS A K-ZERO CONNECTOR ON A FRESENIUS KABI IVENIX ADMINISTRATION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700011 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: ON (B)(6) 2025 FENWAL INTERNATIONAL QE COMPLAINTS ENGINEER RECEIVED A [FRESENIUS KABI] IVENIX COMPLAINT/DISPOSABLE FOR EVALUATION AND DURING EVALUATION THEY FOUND A DEFECT WITH A BLONIE PRODUCT. NO ADVERSE EVENT REPORTED NO SAMPLE AVAILABLE PICTURES AVAILABLE FINDING: DURING SAMPLE EVALUATION THE CAP WAS FOUND TO BE SEPARATED FROM Y-PORT. CRACKED CAP. NOTE: THIS WAS A K-ZERO CONNECTOR ON A FRESENIUS KABI IVENIX ADMINISTRATION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700009 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: ON 11/3/2025 THEY RECEIVED AN IVENIX COMPLAINT/DISPOSABLE FOR EVALUATION AND DURING EVALUATION THEY FOUND A DEFECT WITH A BLONIE PRODUCT. SEE ATTACHED FOR DESCRIPTION OF ISSUE. NO ADVERSE EVENT REPORTED NO SAMPLE AVAILABLE PICTURES AVAILABLE FINDINGS: DURING SAMPLE EVALUATION, TWO DEFECTS WERE IDENTIFIED: -MISSING SILICONE BARRIER -CRACKED CAP NOTE: THIS WAS A K-ZERO CONNECTOR ON A FRESENIUS KABI IVENIX ADMINISTRATION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699854 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: ON 11/3/2025 THEY RECEIVED AN IVENIX COMPLAINT/DISPOSABLE FOR EVALUATION AND DURING EVALUATION THEY FOUND A DEFECT WITH A BLONIE PRODUCT. SEE ATTACHED FOR DESCRIPTION OF ISSUE. NO ADVERSE EVENT REPORTED. NO SAMPLE AVAILABLE. PICTURES AVAILABLE. FINDINGS: DURING SAMPLE EVALUATION, TWO DEFECTS WERE IDENTIFIED: MISSING SILICONE BARRIER, AND A CRACKED CAP. NOTE: THIS WAS A K-ZERO CONNECTOR ON A FRESENIUS KABI IVENIX ADMINISTRATION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699853 ↗