Dynarex Unna Boot Dressing products recalled due to temperature storage excursion
Mckesson Medical-Surgical is recalling Dynarex Unna Boot Dressing products exposed to temperature excursions during June-August 2021. The manufacturer states the deviation is unlikely to cause health consequences, but products may have reduced effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls are typically scored 1 or 2. This recall is precautionary in nature, with the manufacturer explicitly stating the temperature deviation is not likely to cause adverse health consequences. The potential hazard is effectiveness loss rather than immediate health risk.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Dynarex Unna Boot Dressing products (catalog numbers 3453 and 3454, available in 3-inch and 4-inch sizes) due to facility temperature excursions that occurred between June and August 2021 prior to delivery. The exposure to higher temperatures during storage may have impacted the products' effectiveness. The recall affects all lots received between June 1, 2021, and September 30, 2021, and applies to products distributed nationwide.
According to the manufacturer, this device with the specific storage temperature deviation is not likely to cause adverse health consequences.
Consumers with affected products should contact Mckesson Medical-Surgical Inc. or their product distributor to determine whether they have recalled lots and to discuss appropriate actions, such as product replacement or return.
The recalled product
- Product
- a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Wound Care
- Hazard
- temperature-excursion
- effectiveness-loss
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 (1)
- not available
Distribution
Distributed nationwide across the United States.
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