Recall Z-0803-2013— Breg Inc
Class II · Terminated
Class II FDA medical device recall by Breg Inc, initiated 2013-01-14, terminated 2013-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Breg Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-14
- Terminated
- 2013-07-01
- Firm location
- Carlsbad, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.