Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0804-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2013-01-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0804-2013
Date of alert
2013-01-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Breg Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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