Precision Dynamics Recalls Non-Sterile Viscot Surgical Skin Markers
Precision Dynamics Corporation is recalling 1,200 non-sterile Viscot surgical skin markers because they were mislabeled as sterile.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error (non-sterile labeled as sterile) without reported injuries, fitting the Moderate criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Precision Dynamics Corporation is recalling 1,200 units of Non-Sterile Viscot Surgical Skin Markers, Part Number 1437-100. These pen-like devices are intended to be used to write on a patient's skin to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.
The recall was initiated because the non-sterile markers were inadvertently mislabeled as "PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter." This labeling error could lead to the use of non-sterile devices in sterile surgical procedures.
The affected products are distributed in the United States, specifically in the states of South Carolina, Texas, Tennessee, Washington, and Oklahoma. The specific lot number is 061313. Healthcare facilities and consumers should stop using these markers and contact Precision Dynamics Corporation for instructions on return or replacement.
The recalled product
- Product
- Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for…
- Manufacturer
- Precision Dynamics Corporation
- Affected units
- 1,200
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)
- Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.
Distribution
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