Teleflex Visistat 35 Skin Closure Devices Recalled for Labeling Error
Teleflex Medical is recalling Visistat 35 skin closure devices because some boxes are mislabeled as Wide when they contain Regular devices.
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: This is a minor labeling error where the individual units are correctly labeled, fitting the criteria for a moderate severity recall.
Plain-English summary
Teleflex Medical is recalling 12 units of Visistat 35 skin closure devices. These devices are used for the external skin closure of lacerations. The recall is limited to Lot Number 73H1600207, which was distributed in Kansas.
The recall was initiated because some boxes are labeled as Visistat Wide devices, when in fact they contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
Consumers who have these devices should stop using them and contact Teleflex Medical for instructions on how to return the product.
The recalled product
- Product
- Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 12
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 Number 73H1600207
Distribution
Distributed in 1 state:
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