Non-Coring Huber Type Needles

• • Terminated Z-0681-2018 FDA Class II ·initiated 24 Jul 2017

  Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.

• • Terminated Z-1480-2012 FDA Not yet classified ·initiated 16 Apr 2012

  Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label.

510(k) Number

K873957 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Fetal Monitor Model FHM-1

  Class II

  FDA 510(k) K800013 Active Cleared 7 Mar 1980

• Central Display System #CS400

  Class II

  FDA 510(k) K821479 Active Cleared 25 Jun 1982

• Wall Mounted Laser Positioning Device

  Class I

  FDA 510(k) K801541 Active Cleared 20 Aug 1980

• Neonatal Physiological Monitor Model Pm 20

  Class II

  FDA 510(k) K863494 Active Cleared 22 Dec 1986

• Modification Fetal Monitor Model Fm-2

  Class II

  FDA 510(k) K852518 Active Cleared 5 Jul 1985

• Toco Data Telephone Transmitter DT100P

  Class II

  FDA 510(k) K840747 Active Cleared 19 Jun 1984

See all devices from Advantage Medical Systems, Inc. →