Suture Removal Kit

• 3 recalls, same reason

  • Terminated Z-1138-04 FDA Unclassified (pre-2012) ·initiated 12 Jul 2004
  • Terminated Z-1136-04 FDA Unclassified (pre-2012) ·initiated 12 Jul 2004
  • Terminated Z-1137-04 FDA Unclassified (pre-2012) ·initiated 12 Jul 2004

  The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.

510(k) Number

K920340 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SEKD

• Upper Extermity Drape Kit

  Class II

  FDA 510(k) K923960 Active Cleared 7 Oct 1994

• Tracheostomy Care Tray

  Class II

  FDA 510(k) K921733 Active Cleared 15 Jun 1994

• Laceration Trays

  Class II

  FDA 510(k) K920341 Active Cleared 23 Apr 1992

• IV Start Kit

  Class II

  FDA 510(k) K953474 Active Cleared 2 Oct 1995

• C-Section Pack

  Class I

  FDA 510(k) K921730 Active Cleared 15 Jun 1994

• Dressing Change Tray

  Class II

  FDA 510(k) K920339 Active Cleared 23 Apr 1992

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