FDA Device recall Z-0318-2016
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07 by Tz Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0318-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-14 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tz Medical |
| Distribution | AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, WV |
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
Identifiers
| code_info | Lot Numbers: 2012-0809; 2012-0903; 2012-1011. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2016%22
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