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Blue Diamond

David Scott Company · Model BD1618-002 · UDI-DI 15060797551163

FMP

510(k) clearances

239

Adverse events (7 deaths)

Recalls

385

Facilities

Description

Blue Diamond® Peel 'n Stick Gel Sheet that you can cut to the size you need. Clean with water and reuse. Top film contains Silver Ionic Antimicrobial. Great for grips, pressure spots, hard surfaces, pressure management - so many applications. Made in the USA. These are 16" x 18" x 2mm

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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Data 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.