Recall Z-1105-2017 ยท LHC Warmer, Irrigation Solution
Smiths Medical ASD, Inc.
NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperat
| Date | Jan 26, 2017 (initiated Oct 25, 2016) |
| Status | Terminated |
| Reason | Smiths Medical became aware that that one (1) NORMOFLO H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifically five (5) labels were incorrect; the Operators Manual, Outer Base Box label, Pole Assembly Box label, and two (2) O-ring Lube labels. |
| Root cause | Labeling mix-ups |
| Action | Consignee were hand delivered a Smiths Medical Urgent Medical device Filed Safety Notice letter dated October 25, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to Provide the device to the Smiths Medical Representative who delivered this notice to you. The Smiths Medical Representative will replace the labeling on the device and packaging, and provide you with the correct English language Operators Manual. Complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths |
| Quantity | 1 |
| Distribution | Distribution in the foreign country of Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.