Recall Z-1145-2017 ยท LGZ Warmer, Thermal, Infusion Fluid
Smiths Medical ASD, Inc.
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.
| Date | Oct 31, 2016 |
| Status | Terminated |
| Reason | HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 33 |
| Distribution | Internationally to Finland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.