Mix2Vial Transfer Device 900165Recalls & reported problems

West Pharma. Services Il, . Ltd · Mix2Vial 20/20 WR & 15mic L. filter-TG · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290108240801), received between Aug 15, 2022 and Aug 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Contamination3
Device Damaged Prior to Receipt by User1
Particulates1
Product Quality Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 6, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50157968 ↗
MalfunctionAug 6, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50157964 ↗
MalfunctionAug 6, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50157809 ↗
MalfunctionNov 8, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
ON 10OCT2023, THE CUSTOMER, CSL BEHRING, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING PACKAGING OF THE MIX2VIAL TRANSFER DEVICE, LOT H489 WHICH WAS TO BE PACKED WITH A CSL PRODUCT LOT, OPERATORS IDENTIFIED MORE THAN ONE HUNDRED MIX2VIAL DEVICES WITH DEFORMED AND/OR OPENED BLISTERS. CSL BEHRING PERFORMED AN INVESTIGATION ON THIS EVENT. PER THE CUSTOMER, IT WAS CONCLUDED THAT ONE OR MORE PALLETS OF THE MIX2VIAL WERE LIKELY EXPOSED TO A STRONG HEAT SOURCE AS THE TEMPERATURE LABELS ON THE SHIPPING PALLETS HAD SWITCHED FROM SILVER TO BLACK. THIS IS AN INDICATION THAT THE PALLETS WERE EXPOSED TO A TEMPERATURE OF 71 DEGREES CELSIUS OR HIGHER. THE AFFECTED LOT H489 WAS SENT BY PLANE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18095812 ↗
MalfunctionAug 15, 2022Particulates; Product Quality Problem; Particulates; Product Quality Problem
ON 7/18/2022, CSL BEHRING CONTACTED WEST PHARMA. SERVICES IL, LTD. (WEST) TO REPORT THAT PARTICLES HAD BEEN OBSERVED BY (B)(6) IN CSL BEHRING'S DRUG PRODUCT SOLUTION FOLLOWING USE WITH WEST'S TWO UNITS OF MIX2VIAL 20/20MM W/R & 15MICRON LARGE FILTER - TGW (PARTICULATE CONTAMINATION) FROM LOT C883 PRIOR TO USE. CSL BEHRING INVESTIGATION OF THE SAMPLE IDENTIFIED THAT THE PARTICLES MAINLY CONSISTED OF POLYCARBONATE. THE SYRINGE USED FOR ADMINISTERING THE RECONSTITUTED PRODUCT DOES NOT CONSIST OF POLYCARBONATE. THE LUER CONNECTION AND THE FLOW RATE REDUCER OF MIX2VIAL CONSIST OF POLYCARBONATE. IT IS A SINGLE-USE, STERILE DEVICE CONSISTING OF TWO VIAL ADAPTERS CONNECTED TOGETHER THROUGH LUER PORTS. AFTER RECONSTITUTION, THE DRUG IS ADMINISTERED BY DISCONNECTING THE DILUENT VIAL AND CONNECTING A SYRINGE TO THE FEMALE LUER. THE DEVICE IS AND INTENDED TO BE IN INDIRECT CONTACT WITH THE PATIENT BODY TISSUE FOR TRANSIENT USE, I.E. LESS THAN 60 MINUTES. IT IS FOR PRESCRIPTION USE ONLY. PHOTOGRAPHS FROM THE CUSTOMER ARE AVAILABLE UPON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15228717 ↗

Device details

UDI-DI	`07290108240801`
Brand	Mix2Vial Transfer Device
Model	900165
Company	West Pharma. Services Il, . Ltd
Product code	LHI · Set, I.V. Fluid Transfer
Class	Class 2
FDA submission	K031861
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 9, 2019

Device type (GMDN): Medication transfer needle, filtering

A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device.

Other Set, I.V. Fluid Transfer devices

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EXACTAMIX H938741
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EXACTAMIX H938737
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EXACTAMIX H938724
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EXACTAMIX H938173
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All Set, I.V. Fluid Transfer 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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