Recall Z-0603-2016 ยท LGZ Warmer, Thermal, Infusion Fluid
Steris Corporation
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.
| Date | Nov 20, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 2,319 units |
| Distribution | 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, Tur |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111870 | AMSCO WARMING CABINET STERIS Corporation, Jul 29, 2011 |