Recall Z-0318-2016— TZ Medical Inc.
Class II · Terminated
Class II FDA medical device recall by TZ Medical Inc., initiated 2015-10-14, terminated 2016-10-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- TZ Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-14
- Terminated
- 2016-10-24
- Firm location
- Portland, OR, United States
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.