—#142305

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.

FDA product code: LGZ — Warmer, Thermal, Infusion Fluid
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K111870
Affected lot / code info: Serial #'s: 0428014026 - 0432115014

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

The firm, Steris, sent an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated 12/14/2015 to its customers. The letter described the product, problem and actions to be taken. The firm included an updated quick reference magnet for each affected unit with the letter. The customers were instructed to replace your existing magnet with the enclosed magnet. If you have questions regarding this matter, please contact Product Manager, at 440-392-7705 or STERIS Customer Service at 1-800-548-4873.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.

Timeline

Recall initiated: 2015-11-20
Terminated: 2016-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142305. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.