TZ Medical Recalls Mis-Labeled Neptune Plus Hemostatic Pads
TZ Medical is recalling Neptune Plus hemostatic pads because the labels incorrectly state they include an antimicrobial barrier.
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 Moderate because it involves a minor labeling error (mis-labeling) with no reported illnesses or injuries, consistent with the rubric for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
TZ Medical, Inc. is recalling 1,410 units of Neptune Plus hemostatic pads (Part Number 8870-03, Lot R970249). The product is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites, and following surgical incision.
The recall was initiated because the product was mis-labeled. The labels included the statement "WITH ANTIMICROBIAL BARRIER," which should not appear on the label. The source text does not report any illnesses or injuries associated with this labeling error.
The affected units were distributed nationwide to Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Missouri, Mississippi, North Carolina, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, and West Virginia. Consumers and healthcare facilities should stop using the affected pads and contact TZ Medical for further instructions.
The recalled product
- Product
- Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface…
- Manufacturer
- TZ Medical, Inc.
- Category
- Medical Device — Hemostatic Pad
- Hazard
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 (1)
- Lot R970249
Distribution
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