McKesson 73-SCS025Recalls & reported problems

Mckesson Medical-Surgical Inc. · INDICATOR, BIOLOGICAL STEAM SL · 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 20612479159130), received between Oct 15, 2025 and Oct 15, 2025 — 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

Insufficient Information1

Recent adverse event reports

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

InjuryOct 15, 2025Break; Break
DEALER/DISTRIBUTOR REPORTED THAT CUSTOMER STATED 2 VIALS FROM THE SAME BOX EXPLODED IN THEIR HAND WHEN CRACKING THEM OPEN.
Patient problems: Insufficient Information
MAUDE report 23305061 ↗

Device details

UDI-DI	`20612479159130`
Brand	McKesson
Model	73-SCS025
Company	Mckesson Medical-Surgical Inc.
Product code	FRC · Indicator, Biological Sterilization Process
Class	Class 2
FDA submission	K111515
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 26, 2023

Device type (GMDN): Biological sterilization indicator

A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. 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.