Breg Cold Therapy Units Recalled for Potential Sterility Compromise
Breg Inc is recalling Cold Therapy Combination Units with Sterile Polar Pads because packaging damage may have compromised sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where packaging damage may compromise sterility assurance, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Breg Inc is recalling BREG Cold Therapy Combination Units containing Sterile Polar Pads (02356 Rev M, PAD M/U XL STER). The affected units were manufactured between January 2010 and October 2012 and include model numbers 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. The recall involves 44,883 units.
The recall was initiated because Breg determined that some of these products may have sustained damage to the product packaging, which may compromise the product's sterility assurance. The affected products were distributed nationwide in the United States and in Australia, Singapore, Chile, and Latvia.
Users should stop using the affected products and contact Breg Inc for further instructions.
The recalled product
- 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.
- Manufacturer
- Breg Inc
- Category
- Medical Device — Cold Therapy
- Affected units
- 44,883
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Breg Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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