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Blue Diamond
David Scott Company · Model BD2320 · UDI-DI 15060797551729
10
510(k) clearances
239
Adverse events (7 deaths)
4
Recalls
383
Facilities
Description
Blue Diamond® large knee crutch pad is a versatile gel pad that can be used for many applications. It fits snugly in most knee crutches or knee supports. This pad is thicker to offer more pressure relieving attributes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-06-09 | EHOB, Inc. | QC inspection observed that a portion of the lot may have been contaminated with blood. |
| 2015-12-01 | 3M Company - Health Care Business | Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex |
| 2014-10-10 | Philips Medical Systems, Inc. | Mold on gel filled Gel-E and Squishon products |
| 2014-05-28 | Childrens Medical Ventures | The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fu |
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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.