The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."

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 →

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