Z-1260-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- February 18, 2021
- Termination Date
- April 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11768 devices
Product Description
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
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.
Distribution Pattern
Nationwide Distribution in US and international via 2 US distributors (VA and GA)
Code Information
Model PNC-1200, GTIN # (01) 00857893006066, all serial numbers