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Provox Wipes
Atos Medical AB · Model 8243 · UDI-DI 07331791010392
3
510(k) clearances
91
Adverse events (6 deaths)
6
Recalls
142
Facilities
Description
Provox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin.Provox Cleaning Towel is intended for cleaning around the stoma, it will remove oil from the skin. They are indented to use before application of Provox Adhesives. Provox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue.
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 potential risk of in |
| 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 & Dry External Male |
| 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 & Dry External Male |
| 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, BioDerm Liberty Pouch Cl |
| 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 Adhesive Remover Wipes, SK |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.