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FDAOctober 14, 2015device

SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k

What to do

FDA enforcement status: Terminated

Brands named

tz medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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