CLASS I Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
ThermaCor 1200 Disposable Sets Components recalled
Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor, distributed nationwide in the US. The recall was initiated on 18 Feb 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1259-2021
- FDA event ID
- 86808
- Recalling firm
- Smisson-Cartledge Biomedical, Macon, GA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Feb 2021
- FDA classified
- 26 Mar 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Feb 2021 | Recall initiated by company | |
| 26 Mar 2021 | Classified by FDA | +36 days |
| 7 Apr 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Product as listed by the FDA
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
Where it was distributed
Nationwide Distribution in US and international via 2 US distributors (VA and GA)
Questions about this recall
Is ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor recalled?
Yes. Smisson-Cartledge Biomedical recalled ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor on 18 Feb 2021. The recall is Class I and its status is Terminated. Recall number Z-1259-2021.
Why was it recalled?
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Which lots are affected?
Model DNC-1200, GTIN # (01) 00857893006073, all serial numbers
Where was it sold?
Nationwide Distribution in US and international via 2 US distributors (VA and GA)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Smisson-Cartledge Biomedical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | ThermaCor 1200 Disposable Sets Components recalled | Smisson-Cartledge Biomedical | Other | Nationwide |
| Device | CLASS I | ThermaCor 1200 Disposable Sets Components recalled | Smisson-Cartledge Biomedical | Other | Nationwide |
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