SECURE® 66040Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00812496011541), received between Jan 28, 2022 and May 30, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

16 other recalls cover devices cleared under the same FDA submission (K030888); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0335-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CLEAR PLASTIC PARTICULATE WAS OBSERVED BY A HEALTH PROFESSIONAL IN A SECURE 100 ML EMPTY EVA CONTAINER USED TO COMPOUND AND INFUSE A 7-DAY DOSE OF BLINATUMOMAB. THE ISSUE WAS DISCOVERED BY THE NURSE UPON DISCONNECTING THE COMPLETED INFUSION FROM THE PATIENT. THE PARTICLE APPEARED VISUALLY SIMILAR IN COLOR AND TEXTURE TO THE BAG MATERIAL. LOCAL INVESTIGATION RULED OUT COMPOUNDING TOOLS AND TUBING AS THE SOURCE DUE TO THE PARTICLE'S SIZE AND COLOR. NO PATIENT HARM WAS REPORTED. PHOTOGRAPHS OF THE ISSUE WERE PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115755 ↗
• MalfunctionSep 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PARTICULATE WAS IDENTIFIED WITHIN TWO PRODUCT SAMPLES OF PRODUCT 66040 BY THE PHARMACY DURING INSPECTION AFTER FILLING THE BAGS. THE CUSTOMER REPORTED THE BAGS WERE DISCARDED BY THE PHARMACY AND ARE NOT AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703565 ↗
• MalfunctionSep 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PHARMACY TECHNICIANS IDENTIFIED STOCK DILUTIONS PREPARED IN 100 ML SECURE EMPTY BAGS WITH VISIBLE PARTICULATE. THE REPORT INDICATED THE PARTICULATE MATTER IDENTIFIED RESEMBLED A CIRCULAR PLASTIC "FLOATING" PARTICLE "IN THE BAG SOLUTION PRIOR TO FILLING". TWO SAMPLES WERE RETURNED IN A FILLED STATE, BOTH SAMPLES HAD A NON-VENTED DISPENSING PIN INSERTED INTO THE TWIST OFF ADMINISTRATION PORT. ONE PLASTIC CIRCULAR PARTICULATE WAS IDENTIFIED IN BOTH OF THE BAGS RETURNED FOR EVALUATION. BOTH CIRCULAR PARTICULATES MEASURED APPROXIMATELY 3/16" IN DIAMETER AND WERE SIMILAR IN APPEARANCE. AS THE PARTICULATE WAS IDENTIFIED IN THE PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701798 ↗
• MalfunctionMar 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATERS WERE FOUND POST-COMPOUNDING, AFTER INJECTION OF THE BAGS. THE CUSTOMER FURTHER REPORTED "WE TYPICALLY PRODUCE BUPIVACAINE AND ROPIVACAINE DILUTIONS IN THOSE BAGS, AS WELL AS NARCOTIC COMBINATIONS WITH THEM (FENTANYL/BUPIVACAINE OR FENTANYL/ROPIVACAINE COMBINATIONS, AS WELL AS THE SAME WITH HYDROMORPHONE COMBINATIONS). WE ALSO OCCASIONALLY MAKE MIDAZOLAM DILUTIONS IN THOSE BAGS AS WELL. WE USE A PERISTALTIC PUMP WITH A 16G BD NEEDLE TO INJECT THE DILUENT AND DRUG INTO THE BAGS. THE 16G NEEDLE IS USED FOR A MAXIMUM OF 5 PUNCTURES AND THE SECURE BAG IS BEING PUNCTURED ONLY 2 TIMES. WE USE THE SAME COMPOUNDING METHOD FOR THE ALTERNATIVE VENDOR'S BAGS AND WE DO NOT SEE THIS ISSUE." THE CUSTOMER ALSO STATED "THE 'FLOATERS' WERE OFTEN LITTLE PIECES OF PLASTIC OF VARYING SHAPES AND SIZES ("CIRCULAR", SPIRAL, OTHER SHAPES WHICH COULD HAVE MORE JAGGED EDGES). THEY WERE USUALLY TOO SMALL TO SEE OUTSIDE OF A VISUAL INSPECTION BOX, AND WERE THE SAME COLOUR AS THE EVA BAGS THEMSELVES." AS THE FLOATERS WERE NOTED AT THE FILLING PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499987 ↗
• MalfunctionMar 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATERS WERE FOUND POST-COMPOUNDING, AFTER INJECTION OF THE BAGS. THE CUSTOMER FURTHER REPORTED "WE TYPICALLY PRODUCE BUPIVACAINE AND ROPIVACAINE DILUTIONS IN THOSE BAGS, AS WELL AS NARCOTIC COMBINATIONS WITH THEM (FENTANYL/BUPIVACAINE OR FENTANYL/ROPIVACAINE COMBINATIONS, AS WELL AS THE SAME WITH HYDROMORPHONE COMBINATIONS). WE ALSO OCCASIONALLY MAKE MIDAZOLAM DILUTIONS IN THOSE BAGS AS WELL. WE USE A PERISTALTIC PUMP WITH A 16G BD NEEDLE TO INJECT THE DILUENT AND DRUG INTO THE BAGS. THE 16G NEEDLE IS USED FOR A MAXIMUM OF 5 PUNCTURES AND THE SECURE BAG IS BEING PUNCTURED ONLY 2 TIMES. WE USE THE SAME COMPOUNDING METHOD FOR THE ALTERNATIVE VENDOR'S BAGS AND WE DO NOT SEE THIS ISSUE." THE CUSTOMER ALSO STATED "THE 'FLOATERS' WERE OFTEN LITTLE PIECES OF PLASTIC OF VARYING SHAPES AND SIZES ("CIRCULAR", SPIRAL, OTHER SHAPES WHICH COULD HAVE MORE JAGGED EDGES). THEY WERE USUALLY TOO SMALL TO SEE OUTSIDE OF A VISUAL INSPECTION BOX, AND WERE THE SAME COLOUR AS THE EVA BAGS THEMSELVES." AS THE FLOATERS WERE NOTED AT THE FILLING PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499494 ↗
• MalfunctionMar 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATERS WERE FOUND POST-COMPOUNDING, AFTER INJECTION OF THE BAGS. THE CUSTOMER FURTHER REPORTED "WE TYPICALLY PRODUCE BUPIVACAINE AND ROPIVACAINE DILUTIONS IN THOSE BAGS, AS WELL AS NARCOTIC COMBINATIONS WITH THEM (FENTANYL/BUPIVACAINE OR FENTANYL/ROPIVACAINE COMBINATIONS, AS WELL AS THE SAME WITH HYDROMORPHONE COMBINATIONS). WE ALSO OCCASSIONALLY MAKE MIDAZOLAM DILUTIONS IN THOSE BAGS AS WELL. WE USE A PERISTALTIC PUMP WITH A 16G BD NEEDLE TO INJECT THE DILUENT AND DRUG INTO THE BAGS. THE 16G NEEDLE IS USED FOR A MAXIMUM OF 5 PUNCTURES AND THE SECURE BAG IS BEING PUNCTURED ONLY 2 TIMES. WE USE THE SAME COMPOUNDING METHOD FOR THE ALTERNATIVE VENDOR'S BAGS AND WE DO NOT SEE THIS ISSUE." THE CUSTOMER ALSO STATED "THE 'FLOATERS' WERE OFTEN LITTLE PIECES OF PLASTIC OF VARYING SHAPES AND SIZES ("CIRCULAR", SPIRAL, OTHER SHAPES WHICH COULD HAVE MORE JAGGED EDGES). THEY WERE USUALLY TOO SMALL TO SEE OUTSIDE OF A VISUAL INSPECTION BOX, AND WERE THE SAME COLOUR AS THE EVA BAGS THEMSELVES." AS THE FLOATERS WERE NOTED AT THE FILLING PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499418 ↗
• MalfunctionMar 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATERS WERE FOUND POST-COMPOUNDING, AFTER INJECTION OF THE BAGS. THE CUSTOMER FURTHER REPORTED "WE TYPICALLY PRODUCE BUPIVACAINE AND ROPIVACAINE DILUTIONS IN THOSE BAGS, AS WELL AS NARCOTIC COMBINATIONS WITH THEM (FENTANYL/BUPIVACAINE OR FENTANYL/ROPIVACAINE COMBINATIONS, AS WELL AS THE SAME WITH HYDROMORPHONE COMBINATIONS). WE ALSO OCCASIONALLY MAKE MIDAZOLAM DILUTIONS IN THOSE BAGS AS WELL. WE USE A PERISTALTIC PUMP WITH A 16G BD NEEDLE TO INJECT THE DILUENT AND DRUG INTO THE BAGS. THE 16G NEEDLE IS USED FOR A MAXIMUM OF 5 PUNCTURES AND THE SECURE BAG IS BEING PUNCTURED ONLY 2 TIMES. WE USE THE SAME COMPOUNDING METHOD FOR THE ALTERNATIVE VENDOR'S BAGS AND WE DO NOT SEE THIS ISSUE." THE CUSTOMER ALSO STATED "THE 'FLOATERS' WERE OFTEN LITTLE PIECES OF PLASTIC OF VARYING SHAPES AND SIZES ("CIRCULAR", SPIRAL, OTHER SHAPES WHICH COULD HAVE MORE JAGGED EDGES). THEY WERE USUALLY TOO SMALL TO SEE OUTSIDE OF A VISUAL INSPECTION BOX, AND WERE THE SAME COLOUR AS THE EVA BAGS THEMSELVES." AS THE FLOATERS WERE NOTED AT THE FILLING PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499319 ↗
• MalfunctionJan 28, 2022Contamination; Contamination

  IT WAS REPORTED THAT A PLASTIC THREAD LIKE OBJECT AND AN ADDITIONAL PARTICULATE WERE FOUND FLOATING IN A 100 ML 2 PORT EVA BAG CONTAINING THE CHEMOTHERAPY DRUG BLINCYTO. THE PLASTIC THREAD LIKE OBJECT WAS NOTED PRIOR TO ADMINSTRATION TO THE PATIENT. THE THREAD LIKE OBJECT WAS REMOVED INTO A SYRINGE BY THE CUSTOMER AND THE CHEMO BAG WAS SUBSEQUENTLY ADMINISTERED TO THE PATIENT. THE ADDITIONAL PARTICULATE WAS DESCRIBED AS ANOTHER THREAD BUT NO OTHER INFORMATION WAS PROVIDED. THE CUSTOMER STATED THE PATIENT WAS NOT HARMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384672 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030888. One submission often covers many models, so check the product and lot details in each record.

• Z-0343-2025 · Oct 9, 2024 · Open, Classified
  Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0338-2025 · Oct 9, 2024 · Open, Classified
  SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0337-2025 · Oct 9, 2024 · Open, Classified
  SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0336-2025 · Oct 9, 2024 · Open, Classified
  SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0339-2025 · Oct 9, 2024 · Open, Classified
  SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0345-2025 · Oct 9, 2024 · Open, Classified
  Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0340-2025 · Oct 9, 2024 · Open, Classified
  SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0333-2025 · Oct 9, 2024 · Open, Classified
  CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0331-2025 · Oct 9, 2024 · Open, Classified
  VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0342-2025 · Oct 9, 2024 · Open, Classified
  Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0330-2025 · Oct 9, 2024 · Open, Classified
  VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0344-2025 · Oct 9, 2024 · Open, Classified
  Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0334-2025 · Oct 9, 2024 · Open, Classified
  CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0332-2025 · Oct 9, 2024 · Open, Classified
  CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0341-2025 · Oct 9, 2024 · Open, Classified
  SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

…and 1 more.