FDA Medical Device Recalls (openFDA)
TZ Medical Inc.: 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.
- Recall number
- Z-0318-2016
- Recalling firm
- TZ Medical Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-10-14
- Posted
- not on file
- Terminated
- 2016-10-24
- 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
- Root cause
- Other
- 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.
- Quantity
- 10,180 units
- Distribution
- US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.
- Lot, serial or model codes
- Lot Numbers: 2012-0809; 2012-0903; 2012-1011.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 1000127185
- Firm city
- Portland
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28