Recall Z-1145-2017— Smiths Medical ASD, Inc.
Class III · Terminated
Class III FDA medical device recall by Smiths Medical ASD, Inc., initiated 2016-10-31, terminated 2017-11-27. FDA's recall record names no specific 510(k) clearance for this event. Product: HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.. Reason: HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-10-31
- Terminated
- 2017-11-27
- Firm location
- Saint Paul, MN, United States
Product description
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
Reason for recall
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Data sourced from openFDA. This site is unofficial and independent of the FDA.