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3M™ Kerralite Cool™
3M Deutschland GmbH · Model CWL1006 · UDI-DI 04054596952393
10
510(k) clearances
107
Adverse events
6
Recalls
306
Facilities
Description
3M™ Kerralite Cool™ Moisture-Balancing Hydrogel Non-Adhesive Dressing, CWL1006, 5 in x 7 in, 5/ct, 40ct/Cs
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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