Device product
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.
Z-0318-2016
Product summary
- Firm
- TZ Medical Inc.
- Event
- Event 72450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,180 units
- Official record key
device-enforcement:Z-0318-2016
Official wording
Reason: 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
Code information: Lot Numbers: 2012-0809; 2012-0903; 2012-1011.
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.
Derived failure modes
-
Unknown
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