Z-0318-2016Class II

SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07

Name: Z-0318-2016 SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07
Creator: TZ Medical Inc.
Published: 2015-10-14
License: https://open.fda.gov/license/

TZ Medical Inc. / initiated 2015-10-14 / Terminated / root cause: labeling and UDI

FDA source

TZ Medical Inc. began a recall of SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to... on 2015-10-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0318-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Posted: 2015-11-19
Terminated: 2016-10-24
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.
Product code: FRO Dressing, Wound, Drug
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
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 2012-0809; 2012-0903; 2012-1011.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0318-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0318-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18

Product code FRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)