Vial Adapter 8072107Recalls & reported problems

West Pharma. Services Il, . Ltd · Vial Adapter 20mm FLL SIL w/5μm Filter - VF · Class 2

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290108240184), received between Oct 29, 2024 and Nov 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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

Delivered as Unsterile Product3
Unsealed Device Packaging2
Device Damaged Prior to Use1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 20, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Delivered as Unsterile Product; Device Damaged Prior to Use
ON 23OCT2024, THE CUSTOMER, SANOFI PHARMACEUTICAL CONTACTED THE MANUFACTURER, TO REPORT THAT WHEN THE END USER OPENED THE KIT OF THE CO-PACKAGED VIAL ADAPTER, KITTED WITH A SANOFI MEDICINAL PRODUCT, THE PRIMARY PACKAGING OF THE VIAL ADAPTER 20MM W/5MIC FILTER, LOT# H275, WAS COMPROMISED BREACHING STERILITY. THE END USER ADMINISTERED THE DOSE USING ANOTHER VIAL ADAPTER. THERE WAS NO HEALTH IMPACT TO THE END USER AS THIS ISSUE WAS DETECTED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734933 ↗
MalfunctionOct 29, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
ON (B)(6) 2024, THE CUSTOMER, SANOFI PHARMACEUTICAL CONTACTED (B)(6)), TO REPORT THAT TWO (2) VIAL ADAPTER 20MM W/5MIC FILTER, LOT # H275, WERE REJECTED DUE TO OPEN UNSEALED BLISTERS OF THE PRIMARY PACKAGING. WHEN THE END USER OPENED THE KIT, OF THE CO-PACKAGED VIAL ADAPTER, LOT# H275, KITTED WITH A MEDICINAL PRODUCT, THE TYVEK ON THE DEVICE CAME OFF THE VIAL ADAPTER. THERE WAS NO HEALTH IMPACT TO THE END USER AS THIS ISSUE WAS DETECTED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20561980 ↗
MalfunctionOct 29, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
ON (B)(6) 2024, THE CUSTOMER, SANOFI PHARMACEUTICAL CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT TWO (2) VIAL ADAPTER 20MM W/5MIC FILTER, LOT#: H275, WERE REJECTED DUE TO OPEN UNSEALED BLISTERS OF THE PRIMARY PACKAGING. WHEN THE END USER OPENED THE KIT, OF THE CO-PACKAGED VIAL ADAPTER, LOT#: H275, KITTED WITH A MEDICINAL PRODUCT, THE TYVEK ON THE DEVICE CAME OFF THE VIAL ADAPTER. THERE WAS NO HEALTH IMPACT TO THE END USER AS THIS ISSUE WAS DETECTED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20561885 ↗

Device details

UDI-DI	`07290108240184`
Brand	Vial Adapter
Model	8072107
Company	West Pharma. Services Il, . Ltd
Product code	LHI · Set, I.V. Fluid Transfer
Class	Class 2
FDA submission	K001293
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	Jul 23, 2020

Device type (GMDN): Vial/bottle adaptor, non-hermetic

A device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.

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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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