Diatek Connector Assembly Replacement Kit (Cark)

• 2 recalls, same reason

  • Terminated Z-2804-2020 FDA Class II ·initiated 6 Jul 2020
  • Terminated Z-2802-2020 FDA Class II ·initiated 6 Jul 2020

  The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

510(k) Number

K020430 ↗

FDA Product Code

NFK

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Arkive (Tm)

  Class II

  FDA 510(k) K862085 Active Cleared 12 Jan 1987

• Secura Set Primary Admin. Set

  Class II

  FDA 510(k) K830377 Active Cleared 1 Mar 1983

• Diatek Model 700 Thermometer

  Class II

  FDA 510(k) K895703 Active Cleared 7 Dec 1989

• Modification to Arkive(Tm)

  Class II

  FDA 510(k) K872178 Active Cleared 27 Jan 1988

• Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600, CC5500. CC2400PC, CC2800PC, CC3200PC(32 Cm), CC3200PC(36 Cm)

  Class II

  FDA 510(k) K010399 Active Cleared 14 Aug 2001

• Diatek 600 Thermometer System

  Class II

  FDA 510(k) K833568 Active Cleared 10 Jan 1984

See all devices from Diatek, Inc. →