Recalls / —
—#150786
Product
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.
- FDA product code
- LGZ — Warmer, Thermal, Infusion Fluid
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected lot / code info
- S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.
Why it was recalled
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929
Distribution
- Distribution pattern
- Internationally to Finland
Timeline
- Recall initiated
- 2016-10-31
- Terminated
- 2017-11-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #150786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.