The Recall Desk
HighFDA (Devices)·Z-1260-2021·Announced 2021-04-07

ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching 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, fitting the criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smisson-Cartledge Biomedical, LLC is recalling 11,768 ThermaCor 1200 Disposable Sets. These devices are components of the Rapid Thermal Infusion System used to infuse crystalloid, colloid, or blood products, and to warm fluids for patient rewarming or urology irrigation. The recall covers Model PNC-1200 with GTIN # (01) 00857893006066 and all serial numbers.

The recall was initiated following a Toxicological Risk Assessment that identified a potential for aluminum ions to leach into the warmed fluids. The 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. No specific instructions for consumers or healthcare providers are provided in the source text beyond the notification of the risk assessment findings.

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 Systems
Hazard
Affected units
11,768

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 PNC-1200
  • GTIN # (01) 00857893006066
  • 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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