The Recall Desk
ModerateFDA (Devices)·Z-1193-2018·Announced 2018-04-04

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.

What this means for you

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
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: