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Anscare Hydrocolloid Dressing(Sterile)
BENQ MATERIALS CORP. · Model HS-330-2 · UDI-DI 04719745008238
NAE
Prescription
10
510(k) clearances
106
Adverse events
6
Recalls
305
Facilities
Description
Anscare Hydrocolloid Dressings(Sterile) are hydrophilic, occlusive dressings. The flexible outer layer helps isolate the wound against bacterial and other external contamination while the dressing remains intact without leakage. The inner layer maintains a moist wound environment while absorbing excess wound exudate to prevent fluid pooling.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-02-11 | Nelson Innovaions, Llc | Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2016-09-01 | CellEra LLC | Adhesive border was not sticky enough. |
| 2015-09-30 | O-Two Medical Technologies, Inc. | For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches o |
| 2006-11-09 | Embeem Inc. | Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material |
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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.