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APLICARE
MEDLINE INDUSTRIES, INC. · Model APLP10108S · UDI-DI 00618407410102
3
510(k) clearances
91
Adverse events (6 deaths)
6
Recalls
142
Facilities
Description
PAD,PREP,SKIN PROTECTANT,STERILE
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.