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U.S. Department of Health and Human Services

Class 2 Device Recall SilverStat, 887007

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  Class 2 Device Recall SilverStat, 887007 see related information
Date Initiated by Firm October 14, 2015
Create Date November 19, 2015
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-0318-2016
Recall Event ID 72450
Product Classification Dressing, wound, drug - Product Code FRO
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.
Code Information Lot Numbers: 2012-0809; 2012-0903; 2012-1011.
Recalling Firm/
TZ Medical Inc.
17750 SW Upper Boones Ferry Rd Ste 150
Portland OR 97224-7086
For Additional Information Contact John Lubisich
Manufacturer 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
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.