Smisson-Cartledge ThermaCor 1200 Disposable Sets Recalled for Aluminum Leaching Risk
Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential chemical hazard (aluminum leaching) where no injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smisson-Cartledge Biomedical, LLC is recalling 7,118 units of the ThermaCor 1200 Disposable Sets, which are components of the Rapid Thermal Infusion System. These devices are used to infuse crystalloid, colloid, or blood products for volume replacement in trauma or surgery patients, to rewarm patients after surgery or hypothermia, and for irrigation in urology procedures.
The recall was initiated following a Toxicological Risk Assessment that identified a potential for aluminum ions to leach into the fluids being warmed by the system. The affected devices are identified by Model DNC-1200, GTIN # (01) 00857893006073, and include all serial numbers.
The products were distributed nationwide in the US and internationally through two US distributors located in Virginia and Georgia. Customers are being notified of the assessment results. No specific instructions for consumers or healthcare providers are provided in the source text beyond the notification of the risk assessment results.
The recalled product
- Product
- 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
- Manufacturer
- Smisson-Cartledge Biomedical, LLC
- Category
- Medical Device — Infusion System
- Affected units
- 7,118
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model DNC-1200
- GTIN # (01) 00857893006073
- all serial numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by Smisson-Cartledge Biomedical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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See all →- HighThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching
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FDA (Devices) · 2021-04-07
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