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Grafco

Model 3214 · GF HEALTH PRODUCTS, INC. · DI M36832141

FNP — Urinal · Class I · 21 CFR 880.6730

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 (0)

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.

23562019-08: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 6/device2025-10: 0 reports for this device; peer average 1/device08080210
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0802
2023-0802
2024-0206
2025-1001
This device (reports/month)Average device in FNP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — GF HEALTH PRODUCTS, INC.

  • Warning Letter 2011-12-08 GF Health Products, Inc
  • Warning Letter 2011-12-08 GF Health Products, Inc
  • VAI 2016-12-07 GF Health Products, Inc. · 2 citations
  • VAI 2016-12-07 GF Health Products, Inc. · 2 citations
  • NAI 2016-03-25 Gf Health Products · 0 citations
  • NAI 2016-03-25 Gf Health Products · 0 citations
  • VAI 2012-06-12 GF Health Products, Inc · 2 citations
  • VAI 2012-06-12 GF Health Products, Inc · 2 citations
  • NAI 2012-03-07 Gf Health Products · 0 citations
  • NAI 2012-03-07 Gf Health Products · 0 citations
  • OAI 2011-09-23 GF Health Products, Inc · 11 citations
  • OAI 2011-09-23 GF Health Products, Inc · 11 citations
  • VAI 2010-06-03 Gf Health Products · 0 citations
  • VAI 2010-06-03 Gf Health Products · 0 citations