TZ Medical Inc. recalls SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage:…

Recall date

October 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0318-2016

FDA classification

Class II

Brand / firm

TZ Medical Inc.

Sold / distributed

US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.