BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, ...
FDA Device Recall #Z-0803-2013 — Class II — January 14, 2013
Recall Summary
| Recall Number | Z-0803-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 14, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Breg Inc |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 44,883 units |
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
Lot / Code Information
Affected product will be identified by date of manufacture from January 2010 through October 2012.
Other Recalls from Breg Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0231-2024 | Class II | BREG REF 100519-000 WALKER FOLDING WALKER WITH ... | Sep 13, 2023 |
| Z-1901-2017 | Class II | Dressing Knee/Shldr, P/N 02328 Product Usage... | Mar 30, 2017 |
| Z-1905-2017 | Class II | Dressing Shldr, P/N 04908 Product Usage: Th... | Mar 30, 2017 |
| Z-1903-2017 | Class II | Dressing Rect L, P/N 02428 Product Usage: T... | Mar 30, 2017 |
| Z-1908-2017 | Class II | If Hip, Sterile Polar Dressing P/N 10680 Pro... | Mar 30, 2017 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.