SECURE® 66045Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00812496011589), received between Mar 8, 2023 and Feb 23, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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-0339-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER REPORTED "PART OF THE BAG FLOATING INSIDE THE BAG" POST-COMPOUNDING, AFTER INJECTION OF THE BAG, OF ONE SAMPLE. THE PRODUCT WAS FILLED BY THE PHARMACY AND WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. IMAGES OF THE PRODUCT WERE PROVIDED AND NO PARTICULATE COULD BE VISUALLY IDENTIFIED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773135 ↗
• MalfunctionMar 28, 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, IN 10 UNITS. 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 16628219 ↗
• MalfunctionMar 28, 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, IN 13 UNITS. 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 16627369 ↗
• MalfunctionMar 8, 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 16501751 ↗
• MalfunctionMar 8, 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 16501619 ↗
• MalfunctionMar 8, 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 16501552 ↗
• MalfunctionMar 8, 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 16501445 ↗

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-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-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-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.
• 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-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-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-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-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-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-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-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-0335-2025 · Oct 9, 2024 · Open, Classified
  SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; 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.

…and 1 more.