Inman Medical Oil Emulsion Dressing

• 2 recalls, same reason

  • Ongoing Z-1800-2022 FDA Class III ·initiated 25 May 2022 ·on shared 510(k) K921290
  • Ongoing Z-1803-2022 FDA Class III ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K921290 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SN

• Imc Cable/Wire Cover

  Class II

  FDA 510(k) K933382 Active Cleared 27 Jan 1994

• Inman Medical Packing Strip

  Class II

  FDA 510(k) K921291 Active Cleared 21 Jan 1993

• Inman Medical Petrolatum Dressing

  Unclassified

  FDA 510(k) K921289 Active Cleared 10 Nov 1992

• Imc Endoscopic Instrument Holder

  Class II

  FDA 510(k) K933371 Active Cleared 6 Aug 1993

• Inman Endoscopic Blunt Dissector

  Class II

  FDA 510(k) K933169 Active Cleared 19 Apr 1994

• 10.0mm Suction/Irrigation Probe & Tubing Kit

  Class II

  FDA 510(k) K932762 Active Cleared 31 Aug 1993

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