Z-1145-2017 Class III Terminated
FDA device recall Z-1145-2017 was initiated by Smiths Medical ASD, Inc. on Oct 31, 2016 and is designated Class III. Reason for recall: HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling. The recall status is terminated (terminated Nov 27, 2017). Affected quantity: 33.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2017
- Initiation Date
- Oct 31, 2016
- Termination Date
- Nov 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33
Product Description
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.
Reason for Recall
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Distribution Pattern
Internationally to Finland
Code Information
S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1145-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026