Z-0318-2016 Class II Terminated
FDA device recall Z-0318-2016 was initiated by TZ Medical Inc. on October 14, 2015 and is designated Class II. 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 The recall status is terminated (terminated October 24, 2016). Affected quantity: 10,180 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2015
- Initiation Date
- October 14, 2015
- Termination Date
- October 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,180 units
Product Description
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 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
Distribution Pattern
US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.
Code Information
Lot Numbers: 2012-0809; 2012-0903; 2012-1011.