The Recall Desk
HighFDA (Devices)·Z-1258-2021·Announced 2021-04-07

ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets because a toxicological assessment found potential for aluminum ions to leach into warmed fluids.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential chemical hazard (aluminum leaching) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Smisson-Cartledge Biomedical, LLC is recalling the ThermaCor 1200 Disposable Sets, which are components of the Rapid Thermal Infusion System. These devices are used to infuse crystalloid, colloid, or blood products for volume replacement in patients with blood loss, to rewarm patients after surgery or hypothermia, and for irrigation in urology procedures.

The recall is being conducted following the results of a Toxicological Risk Assessment that identified a potential for aluminum ions to leach into the fluids being warmed by the system. The recall covers 18,482 devices, specifically Model PTC-1200 with GTIN (01)00857893006059 and all serial numbers.

The affected devices were distributed nationwide in the US and internationally via two US distributors located in Virginia and Georgia. Customers are being notified of the assessment results regarding the potential aluminum leaching hazard.

The recalled product

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
Manufacturer
Smisson-Cartledge Biomedical, LLC
Category
Medical Device — Infusion System
Hazard
Affected units
18,482

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model PTC-1200
  • GTIN (01)00857893006059
  • all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Smisson-Cartledge Biomedical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Smisson-Cartledge Biomedical, LLC

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Same hazard · chemical leaching

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