Cotton Rolls, Non-Sterile

• 2 recalls, same reason

  • Terminated Z-2158-2013 FDA Class II ·initiated 12 Aug 2013 ·on shared 510(k) K863764
  • Terminated Z-2159-2013 FDA Class II ·initiated 12 Aug 2013 ·on shared 510(k) K863764

  A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility

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

510(k) Number

K863764 ↗

FDA Product Code

EFN

Device Class

Class I

Regulation

21 CFR Part 872.6050

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Evacuator Tips

  Class I

  FDA 510(k) K863769 Active Cleared 30 Oct 1986

• Pediatric Hospital Bed

  Class II

  FDA 510(k) K881843 Active Cleared 26 Oct 1988

• Triangular Bandage

  Not classified

  FDA 510(k) K870284 Active Cleared 24 Feb 1987

• 4 X 4 Sponges, Non-Sterile

  Class I

  FDA 510(k) K870282 Active Cleared 24 Feb 1987

• 2X2 Sponges, Non-Sterile, Cotton Filled

  Unclassified

  FDA 510(k) K863761 Active Cleared 24 Oct 1986

• The Mediscus Pedcare Management System-Model 2

  Class II

  FDA 510(k) K911246 Active Cleared 6 Jun 1991

See all devices from The Medical Group, Inc. →