Devices

Device Recall Various custom surgical kits

  • Modelo / Serial
    (a) Lot Numbers: 42754-1603, 42798-1603, 43030-1604  (b) Lot Numbers: 42696-1602, 43200-1604, 433322-1605  (c) Lot Numbers: 43056-1604,  (d) Lot Numbers: 42836-1603, 43182-1604  (e) Lot Numbers: 42794-1603  (f) Lot Numbers: 42912-1603 (g) Lot Numbers: 43416-1606 (h) Lot Numbers: 43414-1606
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
  • Descripción del producto
    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: || (a) CMS-4153-R2 MPM Biopsy TRAY || (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray || (c) CMS-4108 Multipurpose Safety Tray || (d) CMS-3141-R6 Custom Ultrasound Tray || (e) CMS-2891-R1 Custom Safety Biopsy Tray || (f) CMS-5798-R1 Custom Safety Biopsy Tray || (g) CMS-2357R2 Custom Biopsy Tray || (h) CMS-2540-R4 Custom Biopsy Tray
  • Manufacturer
    Custom Assemblies Inc
  • 1 Event

Fabricante

Custom Assemblies Inc
  • Dirección del fabricante
    Custom Assemblies Inc, 330 E. Main Street, Pine Level NC 27568
  • Empresa matriz del fabricante (2017)
    Custom Assemblies Inc.
  • Source
    USFDA