Skip to content

ThermaCor 1200 Disposable Sets recallZ-1260-2021 · Smisson-Cartledge Biomedical, LLC · initiated Feb 18, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smisson-Cartledge Biomedical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-1260-2021
Status
Terminated
Initiated by the company
Feb 18, 2021
Posted by the FDA
Mar 26, 2021
Recalling firm
Smisson-Cartledge Biomedical, LLC
Quantity
11768 devices
Product code
LGZ
FDA submissions
K052055
Distribution
Nationwide Distribution in US and international via 2 US distributors (VA and GA)

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

Code information (models, lots, serial numbers)

Model PNC-1200, GTIN # (01) 00857893006066, all serial numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

5 devices cleared under K052055 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 86808).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page