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.
FDA Recall Z-0318-2016 · Posted None
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Recalling FirmTZ Medical Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2015-10-14
Date Terminated2016-10-24
Product Quantity10,180 units
Reason for Recall
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
Firm Action
TZ Medical Inc. sent an Urgent: Medical Device Correction 887007 SilverStat letter, dated October 13, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard the Instructions for Use (IFU) in their current inventory and replace with new (IFU). Consignees with questions should call TZ Medical Inc. at (503) 639-0282.
Root Cause
Other
Distribution Pattern
US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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