Device Recall Dressing Back

  • Model / Serial
    D163404
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Dressing Back, P/N 09810 || Product Usage: || These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
  • Manufacturer
  • 1 Event

Manufacturer