Henry Schein 1025804Recalls & reported problems

Henry Schein, Inc. · Maxitest Biological Monitor · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040005149), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

Break1

Patient problems

Laceration(s)1

Recent adverse event reports

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

InjuryAug 7, 2024Break; Break
THE USER FACILITY REPORTED THAT AN ASSISTANT TOOK A SELF-CONTAINED BIOLOGICAL INDICATOR AMPULE/VIAL OUT OF THE STERILIZER. SHE THEN PUT IT IN THE INCUBATOR. WHEN SHE CRACKED OR SNAPPED OFF THE TOP OF THE AMPULE, THE GLASS BROKE, CUT HER, AND THE LIQUID SEEPED INTO THE INCUBATOR CAUSING IT TO START SMOKING. ASSISTANT DID NOT NEED TO GO TO THE HOSPITAL.
Patient problems: Laceration(s)
MAUDE report 19928232 ↗

Device details

UDI-DI	`00304040005149`
Brand	Henry Schein
Model	1025804
Company	Henry Schein, Inc.
Product code	FRC · Indicator, biological sterilization process
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 8, 2019

Device type (GMDN): Sterilization packaging, single-use

A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.