Chrysalis Intelligence · Sponsors · Smisson-Cartledge Biomedical, LLC

Smisson-Cartledge Biomedical, LLC

Macon, GA, US · 1 510(k) clearances · 3 recalls (3 Class I)

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Total clearances
1
2022-08-12 → 2022-08-12
Last 12 months
0
Product codes
1
Most recent
2022-08-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LGZ — — — 1 2022-08-12
Safety

Recalls (3)

Class I (serious)
3
Risk of injury / death
Total recalls
3
Currently ongoing
0
Most recent
2021-02-18
DateSeverityStatusRecall # ProductCodeReason
2021-02-18 Class I Terminated Z-1260-2021 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion S… — Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
2021-02-18 Class I Terminated Z-1259-2021 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion S… — Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
2021-02-18 Class I Terminated Z-1258-2021 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion S… — Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-08-12 K202461 ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System LGZ — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence