Kerlix Md Antimicrobial Gauze Dressing

• 6 recalls, same reason

  • Terminated Z-0018-2019 FDA Class II ·initiated 1 Aug 2018
  • Terminated Z-0013-2019 FDA Class II ·initiated 1 Aug 2018
  • Terminated Z-0015-2019 FDA Class II ·initiated 1 Aug 2018
  • Terminated Z-0017-2019 FDA Class II ·initiated 1 Aug 2018
  • Terminated Z-0016-2019 FDA Class II ·initiated 1 Aug 2018
  • Terminated Z-0014-2019 FDA Class II ·initiated 1 Aug 2018

  Potential for product sterility breach due to a compromised or pinched seal defect

• • Terminated Z-0380-04 FDA Unclassified (pre-2012) ·initiated 8 Jan 2004

  Sterility compromised due to lack of package seal integrity

510(k) Number

K990530 ↗

FDA Product Code

NAD

Device Class

Class I

Regulation

21 CFR Part 878.4020

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Mahurkar Oplus Catheter, Model 13.5 Fr Open recall

  Class II

  FDA 510(k) K030209 Active Cleared 13 May 2003

• Kendall Model 7325 Scd Response Compression System, Model 7325

  Class II

  FDA 510(k) K992079 Active Cleared 29 Sep 1999

• Kendall Argyle Neonatal/Pediatric Picc, Model 43311

  Class II

  FDA 510(k) K061936 Active Cleared 9 Aug 2006

• Filac Fas Temp Electronic Thermometer

  Class II

  FDA 510(k) K003313 Active Cleared 11 Jan 2001

• Tandem-Cath 10 Fr. Catheter System, Model Multiple Code Numbers

  Class II

  FDA 510(k) K002902 Active Cleared 9 Apr 2001

• Excilon Amd Antimicrobial Sponge Model #7088

  Unclassified

  FDA 510(k) K011941 Active Cleared 22 Aug 2001

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