Tissu Trans Filtron, Models 3-Tt-Filtron 2000-500

• 5 recalls, same reason

  • Completed Z-1335-2019 FDA Class II ·initiated 2 Feb 2018
  • Completed Z-1330-2019 FDA Class II ·initiated 2 Feb 2018
  • Completed Z-1336-2019 FDA Class II ·initiated 2 Feb 2018
  • Completed Z-1331-2019 FDA Class II ·initiated 2 Feb 2018
  • Completed Z-1332-2019 FDA Class II ·initiated 2 Feb 2018

  The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

• 2 recalls, same reason

  • Completed Z-1334-2019 FDA Class II ·initiated 2 Feb 2018
  • Completed Z-1333-2019 FDA Class II ·initiated 2 Feb 2018
• • Terminated Z-0170-2018 FDA Class II ·initiated 20 Oct 2017

  Potential breach of sterility of the packaging.

510(k) Number

K092482 ↗

FDA Product Code

MUU

Device Class

Class II

Regulation

21 CFR Part 878.5040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without)

  Class II

  FDA 510(k) K964334 Active Cleared 9 Dec 1996

• Expandacell Injecto-Pak Nasal Pack

  Class I

  FDA 510(k) K960228 Active Cleared 27 Feb 1996

• Expandacell Instrument Wipe

  Class I

  FDA 510(k) K960621 Active Cleared 1 Apr 1996

• Expandacell Anatomical Posterior Nasal Pack W/& Without Airway

  Class I

  FDA 510(k) K955593 Active Cleared 22 Dec 1995

• Expandacell Injecto-Pak

  Class I

  FDA 510(k) K962133 Active Cleared 1 Aug 1996

• Muscle Wand, a Device for Deep Pressure Muscle Massage

  Class I

  FDA 510(k) K963704 Active Cleared 26 Nov 1996

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