Home / Recalls / Breg Inc / Z-0803-2013

Z-0803-2013 Class II Terminated

Recalled by Breg Inc — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
February 20, 2013
Initiation Date
January 14, 2013
Termination Date
July 1, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,883 units

Product Description

BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

Reason for Recall

The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.

Code Information

Affected product will be identified by date of manufacture from January 2010 through October 2012.

Other recalls by Breg Inc

  • Z-0231-2024 Class II — BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking a (September 13, 2023)
  • Z-1905-2017 Class II — Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressing (March 30, 2017)
  • Z-1901-2017 Class II — Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dre (March 30, 2017)
  • Z-1906-2017 Class II — Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dress (March 30, 2017)
  • Z-1903-2017 Class II — Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressin (March 30, 2017)
  • Z-1907-2017 Class II — Dressing Back, P/N 09810 Product Usage: These products are sterile dressings (March 30, 2017)
  • Z-1904-2017 Class II — Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dre (March 30, 2017)
  • Z-1902-2017 Class II — Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressin (March 30, 2017)
  • Z-1908-2017 Class II — If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are s (March 30, 2017)
  • Z-1446-2014 Class II — Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: (March 14, 2014)