Recall Z-0804-2013 ยท ILO Pack, Hot Or Cold, Water Circulating
Breg Inc
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
| Date | Feb 12, 2013 (initiated Jan 14, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | The firm, BREG, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product; complete the Return Response Form by email, Fax or mail; and contact Breg for a Return Authorization for the affected product and request replacement by contacting Breg Customer Care at 800-321-0607. Note: response is required even if you have no affected inventory. Should you have any questions regarding this communication or nee |
| Quantity | 44,883 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920581 | POLAR PAD (STERILE) Breg, Inc., Mar 20, 1992 |