Vial Adapter 8072031Recalls & reported problems

West Pharma. Services Il, . Ltd · Vial Adapter 20mm FLL SIL - SF · Class 2

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 07290108240597), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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

Delivered as Unsterile Product1
Device Damaged Prior to Use1

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.

MalfunctionDec 4, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Delivered as Unsterile Product; Device Damaged Prior to Use
ON 07NOV2024, THE CUSTOMER, BAXTER HEALTHCARE CORPORATION, CONTACTED THE MANUFACTURER TO REPORT THAT VIAL ADAPTER 20MM IN THE BOXES ON TOP OF THE PALLETS APPEAR TO HAVE BEEN DEFORMED UNDER HIGH TEMPERATURES. THE BOXES ALSO APPEAR TO HAVE SOME PARTS DISCOLORED, PROBABLY DUE TO HIGH TEMPERATURES. 11 OF THE 12 SHIPPER BOXES ON TOP OF THE PALLETS HAVE DAMAGED VIAL ADAPTER 20MM. PLEASE NOTE THAT THE SHIPPER BOXES DID NOT APPEAR TO HAVE ANY FORM OF DAMAGED THAT COULD BE ATTRIBUTED TO PHYSICAL DAMAGE. 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 20843637 ↗

Device details

UDI-DI	`07290108240597`
Brand	Vial Adapter
Model	8072031
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.