Cardinal HealthRecalls & reported problems across all models

We found 9 models of Cardinal Health by Jiangsu Caina Medical Co.,Ltd in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Apr 12, 2024 and Nov 6, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (13 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cardinal Health recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 28, 2023Open, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0859-2024 · Root cause: Process change control · Recall details · FDA record ↗

2. Dec 28, 2023Open, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0858-2024 · Root cause: Process change control · Recall details · FDA record ↗

3. Dec 28, 2023Open, Classified

   The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

   Z-0850-2024 · Root cause: Process change control · Recall details · FDA record ↗

4. Dec 28, 2023Open, Classified

   The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

   Z-0849-2024 · Root cause: Process change control · Recall details · FDA record ↗

5. Dec 28, 2023Open, Classified

   The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

   Z-0848-2024 · Root cause: Process change control · Recall details · FDA record ↗

6. Dec 28, 2023Open, Classified

   The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

   Z-0847-2024 · Root cause: Process change control · Recall details · FDA record ↗

Most reported Cardinal Health problems

Cardinal Health models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cardinal Health 1ml

  Enteral Syringes With Enteral Specific Connectors
  1 recall5 reports
• Cardinal Health 35ml

  Enteral Syringes With Enteral Specific Connectors
  1 recall4 reports
• Cardinal Health 60ml

  Enteral Syringes With Enteral Specific Connectors
  1 recall4 reports
• Cardinal Health 3ml

  Enteral Syringes With Enteral Specific Connectors
  1 recall0 reports
• Cardinal Health 6ml

  Enteral Syringes With Enteral Specific Connectors
  1 recall0 reports
• Cardinal Health 12ml

  Enteral Syringes With Enteral Specific Connectors
  1 recall0 reports
• Cardinal Health 1ml 29Gx1/2"

  Syringe, Piston
  3 reports
• Cardinal Health 0.3ml 29Gx1/2"

  Syringe, Piston
  1 report
• Cardinal Health 1mL

  Enteral Syringes With Enteral Specific Connectors
  1 report

Recent Cardinal Health adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THEY HAVE SEEN A SIGNIFICANT UPTICK IN ERROR REPORTS WITH INCORRECT DOSE OF INSULIN GLARGINE AND OTHER SUBCUTANEOUS MEDS THAT ARE PREPARED IN THEIR INPATIENT PHARMACISTS AND TRANSPORTED TO THE NURSING UNIT. FOR EXAMPLE, THEY PREPARE ALL INSULIN GLARGINE DOSES IN PHARMACY AND THE DOSES ARE CHECKED BY THE TECHNICIAN DRAWING UP THE DOSE AND THE PHARMACIST VERIFYING THE DOSE BEFORE THE SYRINGE IS HEAT-SEALED. THE SYRINGE IN THE HEAT-SEALED PLASTIC BAG IS TRANSPORTED BY A TECHNICIAN (EITHER BY HAND OR ON A CART) TO THE NURSING UNIT AND PLACED IN A PLASTIC BIN IN THE REFRIGERATOR. THEN THE NURSE PULLS THE MEDICATION OUT OF THE REFRIGERATOR, REMOVES IT FROM THE HEAT-SEALED BAG (THEY EDUCATE TO CUT OUT WITH SCISSORS, BUT COULD ALSO BE PUSHING OUT), AND THEN IDENTIFIES THE DOSE IS INCORRECT. THEY HAVE SOME INTERNAL OPPORTUNITIES THAT THEY ARE WORKING TO ADDRESS LIKE IMPROVING THEIR DELIVERY PROCESS TO KEEP THE SYRINGES FROM BEING MOVED AND NURSES FROM PUSHING THE PLUNGER. HOWEVER, DUE TO THE INFLUX OF RECENT EVENTS ACROSS THEIR ENTIRE SYSTEM, THEY ARE ALSO CONCERNED THAT THERE MAY BE SOME DEFECT WITH THE SYRINGE THAT MAKES IT LESS STABLE FOR TRANSPORT. THEY PREVIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20617643 ↗
• MalfunctionJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE ORANGE CAP ON THE SYRINGE IS STICKING SO THAT WHEN YOU REMOVE THE CAP THE SAFETY MECHANISM COMES UP AS WELL AND LOCKS OVER THE NEEDLE. THEY HAVE TO WASTE THE NEEDLE WITH THE INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687262 ↗
• MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER STATED SHE HAD A NEW SHIPMENT ARRIVE TODAY AND TESTED ONE OF THE SYRINGES. WHEN YOU PULL THE ORANGE CAP OFF, THE SAFETY ENGAGES UNLESS YOU ACTUALLY HOLD THE SAFETY DOWN. THEN TO REATTACH THE CAP IF NECESSARY, IT IS VERY DIFFICULT TO PUT BACK ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639987 ↗
• MalfunctionJun 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THEY HAD A NEEDLE STICK INJURY DUE TO THE DIFFICULTY OF GETTING THE CAP OFF/ON. ON (B)(6) 2024 THE CUSTOMER STATED THAT THE NEEDLE STICK WAS A CLEAN STICK, HOWEVER IT HAD BEEN IN THE MEDIATION VIAL. SAMPLE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591778 ↗
• MalfunctionJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ANONYMOUSLY VIA MEDWATCH THAT THE CUSTOMER'S FACILITY USES THE MONOJECT ORAL SYRINGES, 1 ML SIZE, FOR ORAL MEDICATIONS NEEDED IN THEIR NICU PATIENTS. STAFF NOTICED THAT THE NEWER VERSION OF THE MONOJECT ORAL SYRINGES FROM CARDINAL HEALTH HAVE A VERY LOOSE PLUNGER. THIS LACK OF RESISTANCE OF THE PLUNGER IN THE BARREL OF THE SYRINGE ALLOWS FOR MEDICATION TO BE EXPELLED OUT OF THE SYRINGE DESPITE BEING CAPPED. THE OLDER/ ORIGINAL VERSION OF THE ORAL MONOJECT 1 ML SYRINGES HAD MORE RESISTANCE WITH THE PLUNGER IN THE BARREL AND DID NOT HAVE THE ISSUE OF THE MEDICATION BEING EXPELLED. THE PRODUCT NUMBER FOR THESE MONOJECT ORAL SYRINGES DID NOT CHANGE WHEN THEY WERE CONVERTED TO THE CARDINAL HEALTH VERSION - PRODUCT NUMBER 8881101015. NO HARM TO ANY PATIENTS BUT PHARMACY STAFF DID HAVE TO RE-DRAW MULTIPLE DOSES FOR PATIENTS DUE TO EXPELLED MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465084 ↗
• MalfunctionApr 14, 2024Compatibility Problem; Compatibility Problem

  THE SYRINGE CAN'T BE USED WITH THE FEEDING PUMPS, THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102960 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT IN THE AM THEY IDENTIFIED A MAJOR PROBLEM WITH THE CARDINAL ENFIT 35 ML SYRING, IT WILL NOT WORK IN THEIR MEDELA FEEDING PUMP. THEY HAVE THE PUMP PROGRAMMED FOR THE ENFIT BRAND AND BIOMED HAS BEEN TO THE UNIT TO EVALUATE AND ARE UNABLE TO CHANGE THE PUMP SETTINGS. THEY DO NOT HAVE ANY OTHER FEEDING PUMPS AVAILABLE TO THE NICU. WHAT WAS IDENTIFIED IS THAT THE NICU HAS BEEN USING THE ENFIT SYRINGES (PURPLE ONES) PER THE CHANGE HOWEVER THEY HAVE BEEN RECEIVING THE COVIDIEN BRAND NOT THE CARDINAL BRAND. TODAY THEY RECEIVED THE CARDINAL BRAND AND THEY DO NOT WORK. THEY LOOK SIMILAR BUT ARE A DIFFERENT DIAMETER. THEY DO NOT WORK IN THE PUMPS. THE WORK AROUND FOR TODAY IS TO USE THE COVIDIEN 60ML SYRINGES. HOWEVER THEY HAVE CONCERNS THAT THEY MAY ALSO BE SWITCHED TO THE CARDINAL BRAND LEAVING NO WORK AROUND TO FEED THE NICU INFANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102792 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THEY HAVE IDENTIFIED THAT THE CARDINAL HEALTH MONOJECT 60ML ENTERAL SYRINGES ARE NOT IDENTIFIED AS MONOJECT SYRINGES IN THE FEEDING PUMPS AND THEREFORE CANNOT DELIVER FEEDS TO BABIES. THIS IS CURRENTLY THE ONLY LOT NUMBER AVAILABLE TO US TO TEST, BUT 100% OF THOSE TESTED HAVE FAILED USING MULTIPLE PUMPS AND PUMP SETTINGS. WE HAVE NOT EXPERIENCED ANY ISSUES WITH THE MONOJECT SYRINGES PACKAGED AS COVIDIEN MONOJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102791 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THEY HAD A FAILURE OF THE CARDINAL MONOJECT SYRINGE - ITEM # 460SE - IN A SYRINGE PUMP. HOWEVER, THE COVIDIEN SYRINGE WITH THE SAME ITEM # 460SE WORKS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102789 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  CUSTOMER REPORTS: THE MEDELA PUMPS ARE REJECTING THE NEW 60ML ENFIT SYRINGES. WE DID MANAGE TO PULL ONE THAT FAILED WHEN PLACED IN THE PUMP. THE ONLY NOTICEABLE DIFFERENCE IS ONE IS MADE IN USA AND THE OTHER MADE IN CHINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102595 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THEY HAVE IDENTIFIED THAT THE CARDINAL HEALTH MONOJECT 60ML ENTERAL SYRINGES (REF (B)(4); LOT 230501) ARE NOT IDENTIFIED AS MONOJECT SYRINGES IN THEIR FEEDING PUMPS AND THEREFORE CANNOT DELIVER FEEDS TO BABIES. THIS IS CURRENTLY THE ONLY LOT NUMBER AVAILABLE TO THEM TO TEST, BUT 100% OF THOSE TESTED HAVE FAILED USING MULTIPLE PUMPS AND PUMP SETTINGS. THEY HAVE NOT EXPERIENCED ANY ISSUES WITH THE MONOJECT SYRINGES PACKAGED AS COVIDIEN MONOJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102591 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THE SYRINGES CANNOT BE USED WITH THE FEEDING PUMPS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096584 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THE SYRINGES CANNOT BE USED WITH THE FEEDING PUMPS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096580 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THE SYRINGES CANNOT BE USED WITH THE FEEDING PUMPS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096579 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THE SYRINGES CANNOT BE USED WITH THE FEEDING PUMPS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096291 ↗