NA 68120Recalls & reported problems

Metrix Company, The · EMPTY EVA CONTAINER With Detachable 3 Leg Transfer Set · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812496011367), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

17 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak1
Leak/Splash1
Mechanical Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 17, 2025Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem
A MEDWATCH REPORT MW5163137 WAS RECEIVED ON 12/19/2024 REPORTING A LEAK ON ONE SAMPLE OF PRODUCT 68120-A8252 CAUSED BY A HOLE IN THE POOLING BAG IN AN UNDISCLOSED LOCATION. THE REPORT INDICATED LIMITED PATIENT INFORMATION BUT DID NOT CONFIRM IF THE FAILURE WAS IDENTIFIED DURING ADMINISTRATION TO THE PATIENT. PRODUCT AND LOT INFORMATION WERE PROVIDED IN THE REPORT. PHOTOS, SAMPLES, LEAK LOCATION, AND DESCRIPTION OF THE HOLE WERE NOT AVAILABLE. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178576 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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.
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.

…and 2 more.

Device details

UDI-DI	`00812496011367`
Brand	NA
Model	68120
Company	Metrix Company, The
Product code	KPE · Container, I.V.
Class	Class 2
FDA submission	K030888
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 9, 2022

Device type (GMDN): Intravenous administration bag/bottle

An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

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All Container, I.V. devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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