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Terminated

Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

FDA Recall Z-2731-2017 · Posted 2017-06-22

Recalling FirmO-Two Medical Technologies, Inc.
Recall StatusTerminated
Product CodeNAE
Date Initiated2015-09-30
Date Terminated2017-09-01
Product Quantity624 units

Reason for Recall

For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief products to prevent potential contamination. .

Firm Action

O-Two sent a Voluntary Recall Notification dated September 30, 2015, to all affected customers. Customers were instructed to acknowledge receipt of the recall notice by fax to 1-905-677-2035; or email to [email protected]. Customers with questions should call 1-905-677-9410. For questions regarding this recall call 905-677-9410 .

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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