ThermaCor 1200 Infusion System PNC-1200Recalls & reported problems

Smisson-Cartledge Biomedical, LLC · Cassette with Patient Line · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857893006066), received between Sep 22, 2020 and Sep 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K052055, K202461); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Feb 18, 2021Class ITerminated
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Z-1260-2021 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Device problems

Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
DURING SURGERY AT (B)(6) MEMORIAL HOSPITAL, THE STAFF NOTICED THE CASSETTE STARTED LEAKING BLOOD AT THE PATIENT LINE CONNECTION TO THE CASSETTE. THE CASSETTE LOT NUMBER WAS LOT 316277. THE HOSPITAL CHANGED OVER TO A LEVEL ONE UNIT TO COMPLETE THE SURGERY. NO PATIENT HARM WAS NOTED BY THE HOSPITAL. THE TUBING WAS RETURNED TO THE DISTRIBUTOR, MEDICAL SOLUTIONS, INC (MSI). MSI FOUND NO ADHESIVE AT THE CASSETTE END OF THE PATIENT LINE WHICH CAUSED THE LEAK AT THE FITTING. RETAINS WERE REVIEWED, AND ADHESIVE WAS PRESENT AT THE CONNECTION. NO OTHER ISSUES HAVE BEEN NOTED FOR THIS LOT. THE DHR WAS REVIEWED; NO ISSUE WAS NOTICED FOR THIS LOT. THE MANUFACTURER HAS BEEN NOTIFIED OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10568031 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052055, K202461. One submission often covers many models, so check the product and lot details in each record.

Z-1258-2021 · Feb 18, 2021 · Terminated
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood p
Z-1259-2021 · Feb 18, 2021 · Terminated
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood

Device details

UDI-DI	`00857893006066`
Brand	ThermaCor 1200 Infusion System
Model	PNC-1200
Company	Smisson-Cartledge Biomedical, LLC
Product code	FRN · Pump, infusion
Class	Class 2
FDA submission	K052055, K202461
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 12, 2023

Device type (GMDN): Conduction blood/fluid warmer

An electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Other Pump, infusion devices

Alaris 8100
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths650,218 reports
Alaris 8100
Carefusion 303, Inc. · Pump, infusion
4 recalls78 deaths344,514 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
2 recalls45 deaths148,093 reports
BD® Alaris™ Pump Module, Model 8100
Carefusion 303, Inc. · Pump, infusion
5 recalls30 deaths51,256 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls4 deaths21,956 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths15,547 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
3 recalls6 deaths13,022 reports
CADD 21-6500-51
Icu Medical, Inc. · Pump, infusion
2 deaths8,231 reports

All Pump, infusion devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page