Recall Z-1259-2021 ยท LGZ Warmer, Thermal, Infusion Fluid
Smisson-Cartledge Biomedical, LLC
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
| Date | Mar 26, 2021 (initiated Feb 18, 2021) |
| Status | Terminated |
| Reason | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. |
| Root cause | Component design/selection |
| Action | The firm issued an URGENT MEDICAL DEVICE SAFETY NOTIFICATION by email and letter on 02/18/2021. The letter explained the issue and the hazard and provided the user with specific parameters for the safe usage of the device. Distributors: Further distribute the product to the hospitals and clinics where they were used. Keep accurate records and send a complete Customer List to: Smisson-Cartledge Biomedical, LLC Attn: Donna Stevenson, 487 Cherry Street Macon, GA 31201 USA Send an updated Customer List on a weekly basis. For additional information contact - Calder Clay 478-330-6203 On 03/3 |
| Quantity | 7118 devices |
| Distribution | Nationwide Distribution in US and international via 2 US distributors (VA and GA) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052055 | SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 Smisson-Cartledge Biomedical, LLC, Oct 26, 2006 |