Class 1 Device Recall ThermaCor

• Date Initiated by Firm: February 18, 2021
• Date Posted: March 26, 2021
• Recall Status: Completed
• Recall Number: Z-1258-2021
• Recall Event ID: 86808
• 510(K)Number: K052055
• Product Classification: Warmer, thermal, infusion fluid - Product Code LGZ
• 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 loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
• Code Information: Model PTC-1200, GTIN (01)00857893006059, all serial numbers
• Recalling Firm/ Manufacturer: Smisson-Cartledge Biomedical, LLC; 487 Cherry St; Third Street Tower; Macon GA 31201-7972
• For Additional Information Contact: Calder Clay; 478-330-6203
• Manufacturer 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.
• FDA Determined 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 03/31/2021, Smisson-Cartledge Biomedical, LLC issued an updated letter, an URGENT MEDICAL DEVICE CORRECTION NOTIFICATION, to its consignees with a laminated card to attach to the pole clamp knob with the following warning: Warning: Use of this device under certain clinical use conditions may result in exposure to aluminum at levels that raise a toxicological concern. To mitigate the risk of exposure to aluminum, users should be aware of the following: 1. Potentially higher aluminum leaching from these devices may occur when using lower flow rates (i.e., 10mL/HOUR), with certain solutions and blood products, and longer duration of use. 2. When possible, the use of balanced electrolyte solutions (e.g., Lactated Ringers solution) should be limited to less than 6 hours. 3. Limit the use of the ThermaCor 1200 Rapid Thermal Infuser and Cassettes to a maximum total fluid volume of 25 Liters or up to a maximum of 12 consecutive hours, whichever occurs first. 4. The following patient populations are especially at risk: Pediatric patients, particularly neonates and infants, Pregnant women, Elderly, Patients with poor renal function or on dialysis 5. Evaluate the benefits and risks of using the device versus the patient condition. Note: These parameters do not reflect typical clinical usage. NO RETURN OF THE PRODUCT IS NECESSARY.
• Quantity in Commerce: 18482 devices
• Distribution: Nationwide Distribution in US and international via 2 US distributors (VA and GA)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = LGZ and Original Applicant = SMISSON-CARTLEDGE BIOMEDICAL LLC