Recall Z-0951-2017— Natus Manufacturing Limited
Class II · Terminated
Class II FDA medical device recall by Natus Manufacturing Limited, initiated 2016-10-15, terminated 2019-06-24. It names one FDA 510(k) clearance: K132110. Product: Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items. Reason: The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly..
- Recalling firm
- Natus Manufacturing Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-15
- Terminated
- 2019-06-24
- Firm location
- GORT, Galway, Ireland
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
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
Reason for recall
The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.