Z-1105-2017 Class II Terminated
FDA device recall Z-1105-2017 was initiated by Smiths Medical ASD, Inc. on Oct 25, 2016 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jul 25, 2017). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 1, 2017
- Initiation Date
- Oct 25, 2016
- Termination Date
- Jul 25, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
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 temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.
Reason for Recall
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.
Distribution Pattern
Distribution in the foreign country of Sweden
Code Information
S105B0061
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1105-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026