Recall Z-0804-2013
Breg Inc · initiated January 14, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Affected product will be identified by date of manufacture from January 2010 through October 2012
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.
FDA-determined cause: Packaging
Action taken
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 need to report an adverse event, please contact Breg Customer Care at 800-321-0607.
Details
- Recall number
- Z-0804-2013
- Initiated
- January 14, 2013
- Posted by FDA
- February 12, 2013
- Terminated
- July 1, 2013
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Quantity
- 44,883 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
- Recalling firm
- Breg Inc, Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0803-2013 Class II | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U…The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from… | 01/14/2013Terminated |