Reported Nov 25, 2015 · Terminated
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage:…
TZ Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TZ Medical Inc. · 17750 SW Upper Boones Ferry Rd Ste 150 · Portland, OR · 97224-7086
Is this the product you have?
- SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07
- Product UsageSilverStat 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
- Lot codes and dates
- Lot Numbers
2012-08092012-09032012-1011
- Lot Numbers
- Amount recalled
- 10,180 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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