TZ Medical Recalls SilverStat Hemostasis Pads Due to Labeling Discrepancy
TZ Medical Inc. is recalling 10,180 units of SilverStat hemostasis pads because the instructions for use did not match the original FDA submission.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a documentation discrepancy (IFU mismatch) without reporting any illnesses, injuries, or specific health hazards, aligning with the criteria for moderate severity involving minor labeling or documentation issues.
Plain-English summary
TZ Medical Inc. is recalling 10,180 units of SilverStat, sterile 2" x 2" calcium alginate hemostasis pads with silver nitrate. The recall was initiated after a review revealed that the instructions for use (IFU) provided with the product did not match the version submitted in the original 510(k) application to the FDA.
The affected product is indicated for external use only as a barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, and surgical wounds. The recall covers specific lot numbers: 2012-0809, 2012-0903, and 2012-1011.
The product was distributed in the United States to the states of Alabama, Arkansas, California, District of Columbia, Florida, Georgia, Iowa, Maryland, North Carolina, Nebraska, New Hampshire, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, and West Virginia. Consumers and healthcare providers should stop using the affected lots and contact TZ Medical Inc. for further instructions.
The recalled product
- 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…
- Manufacturer
- TZ Medical Inc.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 10,180
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: 2012-0809
- 2012-0903
- 2012-1011.
Distribution
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