Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 15, 2017
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.
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Smiths Medical Asd, Inc. recalled HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Wa… - a low-severity action.
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Wa… was recalled by Smiths Medical Asd, Inc. in February 15, 2017. Reason: HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish l…. Check the official notice for the remedy. Verify recall #Z-1145-2017 with the FDA Devices before acting.
The recall
Smiths Medical Asd, Inc. issued this low-severity FDA Devices recall-HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish l….
- Low
- severity level
- 33 units
- affected scope
- Class III
- classification
- February 15, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1145-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1145-2017) was formally reported on February 15, 2017, with the manufacturer initiating the action on October 31, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Smiths Medical Asd, Inc. is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 33.
The documented reason for this recall is: HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling. Distribution data in the federal record shows the product reached: Internationally to Finland. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
33
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1145-2017 |
| Date reported | February 15, 2017 |
| Date initiated | October 31, 2016 |
| Recalling firm | Smiths Medical Asd, Inc. |
| Firm location | Saint Paul, MN |
| Affected scope | 33 |
| Distribution | Internationally to Finland |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1145-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smiths Medical Asd, Inc.. Units affected: 33.
Why was this product recalled? ▼
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Low. Recall number: Z-1145-2017.
Where was the recalled product distributed? ▼
Distribution: Internationally to Finland.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1145-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 15, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.