O-Two Medical Recalls Burn Relief Dressings Due to Sterilization Concerns
O-Two Medical Technologies is voluntarily recalling specific lots of Burn Relief hydrogel dressings because there is a lack of evidence validating the sterilization dose, posing a potential contamination risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves potential contamination of a medical device used on open wounds (burns). No illnesses or injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
O-Two Medical Technologies, Inc. has announced a voluntary recall of specific batches of Burn Relief products. These products are self-cooling, non-adhering hydrogel dressings intended for the treatment of first and second-degree burns. The recall involves 624 units of models 06BK1221, 06BK1232, 06BK1201, and 06BK1200.
The recall was initiated due to a lack of evidence to validate the effectiveness of the sterilization dose used for these products. This deficiency creates a potential risk of contamination. The affected lots are 1150, 1152, and 5210, with expiration dates ranging from July 2018 to July 2020.
The affected products were distributed worldwide, including in the United States (nationwide), Canada, Belgium, Norway, and Malaysia. Consumers and healthcare providers should stop using these specific lots and contact the manufacturer for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- O-Two Medical Technologies, Inc.
- Category
- Medical Device — Wound Dressing
- Affected units
- 624
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot/Batch#1150
- 1152
- 5210
- Expiration date: Jul.2018 (for lot 5210)
- July 2020 (for lot 1150
- 1152)
Distribution
Distributed nationwide across the United States.
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