The Recall Desk
HighFDA (Devices)·Z-2083-2020·Announced 2020-05-27

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.

What this means for you

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

Distributed in 3 states:

Related recalls

Same hazard · foreign material

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