Home › Device types › NEC
Bandage, Liquid, Skin Protectant
FDA product code NEC · Class 1 · General Hospital
114
Registered devices
91
Adverse events
6
Recalls
3
510(k) clearances
Devices with this code
Durma+ Unna Boot Bandage with Zinc Oxide and Calamine — Dynarex CorporationBrava — Coloplast A/SMH — Mazza Healthcare LLCUnnaRite w/Zinc Calamine Healogics by DermaRite — Sion Brands LLCSting Free Wand — Sion Brands LLCMedline — MEDLINE INDUSTRIES, INC.MEDLINE — MEDLINE INDUSTRIES, INC.Meijer Blister Guard Spray — MEIJER, INC.CARDINAL HEALTH — Cardinal Health 200, LLCAdapt — HOLLISTER INCORPORATEDProCure — Twin Med, LLCMEDLINE — MEDLINE INDUSTRIES, INC.Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanySecuri-T — HOLLISTER INCORPORATEDColoplast — Coloplast A/SUnnaRite — Sion Brands LLCAvaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanyColoplast — Coloplast A/SSion Biotext Medical Ltd. — SION BIOTEXT MEDICAL LTDAPLICARE — MEDLINE INDUSTRIES, INC.Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanyColoplast — Coloplast A/SActivon Manuka Honey Barrier Cream — BRIGHTWAKE LIMITEDUnnaRite C — Sion Brands LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-30 | MEDLINE INDUSTRIES INC | Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold. |
| 2012-06-18 | Safe N Simple, LLC | The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a |
| 2011-05-31 | BioDerm, Inc. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean |
| 2011-05-31 | BioDerm, Inc. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean |
| 2011-05-31 | BioDerm, Inc. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioD |
| 2011-04-04 | Smith & Nephew Inc. | Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesi |
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