Simpurity Hydrogel Wound Dressing Recalled Due to Unqualified Sterilization Process
Safe N Simple, LLC is recalling Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a process failure (unqualified sterilization) without reported adverse events, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate score.
Plain-English summary
Safe N Simple, LLC is recalling Simpurity Hydrogel Absorbent Sheet Wound Dressings, 4" x 5", 10 Pads, Catalogue number SNS58315. The recall involves 104 cases of the product, identified by lot number 18060563.
The recall was initiated because the sterilization process used for the product was unqualified. This means the process was not validated to ensure the product was sterile as required.
The product was distributed in California (CA). Consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
- Manufacturer
- Safe N Simple, LLC
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 104
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)
- lot number 18060563
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Safe N Simple, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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