Z-1259-2021Class I

ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal...

Name: Z-1259-2021 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal...
Creator: Smisson-Cartledge Biomedical, LLC
Published: 2021-02-18
License: https://open.fda.gov/license/

Smisson-Cartledge Biomedical, LLC / initiated 2021-02-18 / Terminated / root cause: design

FDA source

Smisson-Cartledge Biomedical, LLC began a recall of ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid... on 2021-02-18. FDA classified it as Class I and gives the reason as "Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1259-2021
Classification: Class I
Status: Terminated
Initiated: 2021-02-18
Posted: 2021-03-26
Terminated: 2024-04-26
Recalling firm: Smisson-Cartledge Biomedical, LLC
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
Product code: LGZ Warmer, Thermal, Infusion Fluid
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.
Root cause tag: design
FDA 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 03/31/2021, 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: 7118 devices
Distribution: Nationwide Distribution in US and international via 2 US distributors (VA and GA)
Product codes and lots: Model DNC-1200, GTIN # (01) 00857893006073, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1259-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1258-2021	Class I	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-26
Z-1259-2021	Class I	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-26
Z-1260-2021	Class I	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-26

Product code LGZ

K052055Class IISmisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC / cleared 2006-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)