Manufacturers

Custom Healthcare Systems, Inc.

3 devices in the database

Device Recall Breast Biopsy Kit
  • Model / Serial
    LOT NO. 60812 EXPIRES: 11 /2012
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
  • Product Description
    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. || Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Device Recall Breast Biopsy tray
  • Model / Serial
    LOT NO. 100212 EXPIRES: 06/2013
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
  • Product Description
    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. || Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Device Recall Safety PICC Insertion Tray with Chloraprep OneStep
  • Model / Serial
    Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to CT.
  • Product Description
    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.