Recall record at a glance
| Official record | Z-1145-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Smiths Medical ASD, Inc. |
| Report date | Feb 15, 2017 |
| Recall initiation date | Oct 31, 2016 |
| Quantity | 33 |
| Location | Saint Paul, MN, United States |
Official 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.
Why the product was recalled
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Distribution information
Internationally to Finland
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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