🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: October 14, 2015 TZ Medical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 2012-0809; 2012-0903; 2012-1011.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
TZ Medical Inc.
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Lot Numbers: 2012-0809; 2012-0903; 2012-1011.

Distribution:

Distributed in: US, AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0318-2016

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