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Ecolab

Model Hush Slush Equipment · Microtek Medical LLC · DI 50748426126731

LHC — Warmer, Irrigation Solution · Class I · 21 CFR 890.5950

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (2)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 2

12232021-09: 0 reports for this device; peer average 3/device2024-09: 1 reports for this device; peer average 1/device2024-10: 1 reports for this device; peer average 1/device090910
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0903
2024-0911
2024-1011
This device (reports/month)Average device in LHC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Microtek Medical LLC

  • NAI 2025-04-22 MICROTEK MEDICAL LLC · 0 citations
  • NAI 2018-06-15 MICROTEK MEDICAL LLC · 0 citations
  • VAI 2016-08-03 Microtek Medical Inc · 4 citations
  • NAI 2011-06-22 Microtek Medical Inc · 0 citations