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Recall Observatory FDA recall evidence

Device product

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.

Z-2731-2017

September 30, 2015

Class II

Product summary

Firm
O-Two Medical Technologies, Inc.
Event
Event 77534
Status
Terminated
Classification
Class II
Quantity
624 units
Official record key
device-enforcement:Z-2731-2017

Official wording

Reason: 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. .

Code information: Lot/Batch#1150, 1152, 5210; Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152)

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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. .