Recall Z-1145-2017
Smiths Medical ASD, Inc. · initiated October 31, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.
Reason for recall
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
FDA-determined cause: Labeling mix-ups
Action taken
Smiths Medical sent an Urgent-Medical Device Field Safety Notice dated October 28, 2016, to all affected customers. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to notify customers and to review and complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths-medical.com. For further questions, please call (651) 633-2556.
Details
- Recall number
- Z-1145-2017
- Initiated
- October 31, 2016
- Terminated
- November 27, 2017
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Quantity
- 33
- Distribution
- Internationally to Finland
- Recalling firm
- Smiths Medical ASD, Inc., Saint Paul, MN