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Blue Diamond

David Scott Company · Model BD010-S · UDI-DI 15060797551095

FMP

510(k) clearances

239

Adverse events (7 deaths)

Recalls

383

Facilities

Description

Pediatric Stirrups Straps are designed to support small infants to approximately two years in age when in an infant stirrup that has a clip to attach these lloped straps. Assists in placing the patient in lithotomy position when access to the perineum is required. Flexible construction allows for infinite adjustment of position. Disposable loop style straps help avoid cross contamination from patient to patient. Quick set-up. Disposable loop style straps are sold separately (BD010-S). Sold as a case of 10 each.

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.