Smisson-Cartledge ThermaCor 1200 Disposable Sets: Aluminum Leaching Risk
Smisson-Cartledge recalls ThermaCor 1200 Disposable Sets due to potential aluminum ions leaching into warmed fluids. Affected units include specific models and serial numbers sold for medical use.
Lower-risk recall
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Contact the company
What happened, in plain English
Smisson-Cartledge is recalling ThermaCor 1200 Disposable Sets because aluminum ions might leach into warmed fluids used in medical treatments. This could pose a risk to patients receiving these infusions. Read more at govinfonow.com/recall/63260-smisson-cartledge-thermacor-1200-disposable-sets-aluminum-leaching-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63260-smisson-cartledge-thermacor-1200-disposable-sets-aluminum-leaching-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1259-2021
Cite this page
“Smisson-Cartledge ThermaCor 1200 Disposable Sets: Aluminum Leaching Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63260-smisson-cartledge-thermacor-1200-disposable-sets-aluminum-leaching-risk. Based on FDA recall #Z-1259-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1259-2021%22&limit=1).
Why it’s dangerous
Aluminum ions may leach into warmed fluids during medical treatments. This could potentially cause health issues for patients receiving these infusions, though the risk level is low based on the toxicological assessment.
Who’s affected
Patients using ThermaCor 1200 Disposable Sets for blood volume replacement, surgery recovery, or urology irrigation are affected. Healthcare providers using these sets for medical procedures are most at risk.
How to tell if you have this one
Check for model DNC-1200 with serial numbers listed in the recall notice. These sets are used for blood volume replacement, surgery recovery, or urology irrigation procedures.
- Brand
Smisson-Cartledge- Product
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide Distribution in US and international via 2 US distributors (VA and GA)
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1258-2021 | 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; Model PTC-1200, GTIN (01)00857893006059, all serial numbers | 18482 devices |
| Z-1259-2021 | 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; Model DNC-1200, GTIN # (01) 00857893006073, all serial numbers | 7118 devices |
| Z-1260-2021 | 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; Model PNC-1200, GTIN # (01) 00857893006066, all serial numbers | 11768 devices |
What to do — step by step
Check Product Details
Identify if your ThermaCor 1200 Disposable Sets have model DNC-1200 and the listed serial numbers.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Distribution in US and international via 2 US distributors (VA and GA)” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1259-2021 (February 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1259-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.