Smiths Medical Recalls NORMFlow H-1100 Irrigation Fluid Warmer for Labeling Errors
Smiths Medical is recalling one NORMFlow H-1100 Irrigation Fluid Warmer in Sweden due to incorrect Spanish labels instead of English.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a labeling error (Spanish instead of English) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Smiths Medical ASD, Inc. is recalling one (1) NORMFlow H-1100 Irrigation Fluid Warmer, Model H-1100, Reorder H-1100-INT-230. The device is designed for the safe, in-line warming of irrigating fluids administered to patients in clinical situations requiring rapid irrigation.
The recall was initiated because the unit was incorrectly labeled with Spanish language labels instead of English labels. Specifically, five (5) labels were incorrect: the Operator's Manual, the Outer Base Box label, the Pole Assembly Box label, and two (2) O-ring Lube labels.
The affected unit was distributed in the foreign country of Sweden. The source text does not specify further instructions for consumers or healthcare providers regarding the disposition of the device.
The recalled product
- Product
- 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
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- S105B0061
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02