Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0318-2016 — 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, di

U.S. FDA — Device Enforcement · United States · 2015-10-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0318-2016
Date of alert: 2015-10-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: TZ Medical Inc.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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