Smisson-Cartledge Biomedical recalls ThermaCor 1200 disposable sets due to potential aluminum leaching into warmed fluids. Affected units include all models with serial numbers and GTIN 0100857893006059.
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Smisson-Cartledge Biomedical is recalling ThermaCor 1200 disposable sets used for medical fluid infusion. Aluminum ions may leach into warmed fluids, potentially causing health risks. This recall affects all units sold with specific serial numbers and GTIN.
The sets may release aluminum ions into warmed fluids. This could lead to aluminum buildup in the body, though the risk is not described as causing serious injury in normal use.
Patients using ThermaCor 1200 sets for blood volume replacement, surgery recovery, or urology irrigation are affected. Healthcare providers using these sets for warmed fluid applications are most at risk.
Check for the model PTC-1200, GTIN 0100857893006059, and all serial numbers on the product. These sets are used for medical fluid infusion in hospitals and clinics.
Identify the model number (PTC-1200), GTIN (0100857893006059), and serial numbers on the ThermaCor 1200 disposable sets.
The recall indicates potential for aluminum ions to leach into warmed fluids, but the risk is not described as causing serious injury in normal use.
Look for model PTC-1200, GTIN 0100857893006059, and all serial numbers on the ThermaCor 1200 disposable sets used for medical fluid infusion.
The recall record does not specify any remedy or action for the product.
We’ve drafted a message you can send Smisson-Cartledge Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1258-2021 — Smisson-Cartledge Biomedical Smisson-Cartledge Biomedical Hello, I own a Smisson-Cartledge Biomedical that is covered by recall Z-1258-2021 from Smisson-Cartledge Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
