Recall Z-0603-2016— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2015-11-20, terminated 2016-10-27. It names one FDA 510(k) clearance: K111870. Product: AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.. Reason: The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-20
- Terminated
- 2016-10-27
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
Reason for recall
The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.
Data sourced from openFDA. This site is unofficial and independent of the FDA.