FDA recall Z-1313-2024

Product

Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

Reason for recall

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Distribution

US Nationwide distribution in the states of AZ, PA and TX.

Key facts

Status

Ongoing

Initiation date

2024-01-09

Report date

2024-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2024