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Ballard* Mini-Bal Prep Pack with Specimen Trap

Model 12393 · Avanos Medical, Inc. · DI 00609038123936

MMO — Tray, Surgical, Ent · Class I · 21 CFR 874.4420

UDILibrary device dossier · generated 2026-09-13 · 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 (7)

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.

Injury: 7

24572019-09: 7 reports for this device; peer average 7/device09
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0977
This device (reports/month)Average device in MMO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Avanos Medical, Inc.

  • Warning Letter 2013-04-10 Avanos Medical, Inc.
  • Warning Letter 2013-04-10 Avanos Medical, Inc.
  • Warning Letter 2008-12-22 Avanos Medical, Inc.
  • Warning Letter 2008-12-22 Avanos Medical, Inc.
  • VAI 2023-12-15 Avanos Medical, Inc. · 3 citations
  • VAI 2023-12-15 Avanos Medical, Inc. · 3 citations
  • VAI 2018-10-02 Avanos Medical, Inc. · 1 citations
  • VAI 2018-10-02 Avanos Medical, Inc. · 1 citations
  • VAI 2016-07-29 Avanos Medical, Inc. · 1 citations
  • VAI 2016-07-29 Avanos Medical, Inc. · 1 citations
  • NAI 2014-11-05 Avanos Medical, Inc. · 0 citations
  • NAI 2014-11-05 Avanos Medical, Inc. · 0 citations
  • VAI 2014-03-07 Avanos Medical, Inc. · 4 citations
  • VAI 2014-03-07 Avanos Medical, Inc. · 4 citations
  • NAI 2013-12-10 Avanos Medical, Inc. · 0 citations
  • NAI 2013-12-10 Avanos Medical, Inc. · 0 citations
  • OAI 2013-01-04 Avanos Medical, Inc. · 6 citations
  • OAI 2013-01-04 Avanos Medical, Inc. · 6 citations
  • OAI 2012-10-31 Avanos Medical, Inc. · 10 citations
  • OAI 2012-10-31 Avanos Medical, Inc. · 10 citations
  • VAI 2011-07-08 Avanos Medical, Inc. · 8 citations
  • VAI 2011-07-08 Avanos Medical, Inc. · 8 citations
  • OAI 2010-11-19 Avanos Medical, Inc. · 4 citations
  • OAI 2010-11-19 Avanos Medical, Inc. · 4 citations