Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 18, 2012
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments
HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Smiths Medical Asd, Inc. recalled Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usag… - a moderate-severity action.
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usag… was recalled by Smiths Medical Asd, Inc. in July 18, 2012. Reason: HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswit…. Check the official notice for the remedy. Verify recall #Z-1979-2012 with the FDA Devices before acting.
The recall
Smiths Medical Asd, Inc. issued this moderate-severity FDA Devices recall-HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswit….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- July 18, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1979-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1979-2012) was formally reported on July 18, 2012, with the manufacturer initiating the action on June 27, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Smiths Medical Asd, Inc. is listed as the recalling firm, operating out of Rockland, MA. Federal records list the affected scope as 2247 units.
The documented reason for this recall is: HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable Distribution data in the federal record shows the product reached: US Nationwide Distribution. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2247 units
Related Recalls
6
3 from same agency
Product description
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments
Reason for recall
HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1979-2012 |
| Date reported | July 18, 2012 |
| Date initiated | June 27, 2012 |
| Recalling firm | Smiths Medical Asd, Inc. |
| Firm location | Rockland, MA |
| Affected scope | 2247 units |
| Distribution | US Nationwide Distribution |
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-1979-2012) 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? ▼
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments. Recalled by Smiths Medical Asd, Inc.. Units affected: 2247 units.
Why was this product recalled? ▼
HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-1979-2012.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1979-2012) 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 July 18, 2012. 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.