NelDerm Hydrogel Dressing Recalled for Foreign Material in Packaging
Nelson Innovations is recalling NelDerm Hydrogel Dressings due to foreign material near the adhesive edge within the pouch packaging.
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 presence of foreign material in a medical device poses a risk of harm where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Nelson Innovations, LLC is recalling 100 units of NelDerm Hydrogel Dressing (Product #: HB66T, Lot #90971). The affected product consists of a 6 x 6 inch dressing with a 4 x 4 inch pad. The recall was initiated because foreign material was found near or along the edge of the hydrogel adhesive within the pouch packaging.
The recalled units were distributed in California, North Carolina, and Puerto Rico. No specific dates or additional distribution details are provided in the source text.
Consumers who possess this specific lot of NelDerm Hydrogel Dressing should stop using the product and contact the recalling firm for instructions on how to return or dispose of the item.
The recalled product
- Product
- NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
- Manufacturer
- Nelson Innovaions, Llc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 100
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 #90971
Distribution
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