Agency classClass IOur severity:Severe FDA (Devices)·Z-1259-2021·Announced 2021-04-07

Smisson-Cartledge ThermaCor 1200 Disposable Sets Recalled for Aluminum Leaching Risk

Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching 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 7,118 units of 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 trauma or surgery patients, to rewarm patients after surgery or hypothermia, and for irrigation in urology procedures.

The recall was initiated following a Toxicological Risk Assessment that identified a potential for aluminum ions to leach into the fluids being warmed by the system. The affected devices are identified by Model DNC-1200, GTIN # (01) 00857893006073, and include all serial numbers.

The products were distributed nationwide in the US and internationally through 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 results.

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…
Manufacturer: Smisson-Cartledge Biomedical, LLC
Category: Medical Device — Infusion System
Hazard: chemical-leaching
aluminum-exposure
Affected units: 7,118

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 DNC-1200
GTIN # (01) 00857893006073
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 →

Same manufacturer · Smisson-Cartledge Biomedical, LLC

See all →

Severe
ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching
FDA (Devices) · 2021-04-07
Severe
ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching
FDA (Devices) · 2021-04-07

Same hazard · chemical leaching