ThermaCor 1200 Disposable Sets Components of the recall
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of…
Why was ThermaCor 1200 Disposable Sets Components of the recalled?
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model PTC-1200, GTIN (01)00857893006059, all serial numbers
- Product
- ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of…
- Recalling firm
- Smisson-Cartledge Biomedical, LLC
- Quantity
- 18482 devices
- Distribution
- Nationwide Distribution in US and international via 2 US distributors (VA and GA)
- Recall date
- April 7, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)