Recall Z-0804-2013— Breg Inc
Class II · Terminated
Class II FDA medical device recall by Breg Inc, initiated 2013-01-14, terminated 2013-07-01. It names one FDA 510(k) clearance: K920581. 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.. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.