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Class 2 Device Recall SilverStat, 887007 |
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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
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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.
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Code Information |
Lot Numbers: 2012-0809; 2012-0903; 2012-1011. |
Recalling Firm/ Manufacturer |
TZ Medical Inc. 17750 SW Upper Boones Ferry Rd Ste 150 Portland OR 97224-7086
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For Additional Information Contact |
John Lubisich 503-639-0282
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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
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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