The Recall Desk
ModerateFDA (Devices)·Z-1996-2015·Announced 2015-07-15

Stradis Healthcare Recalls Endovenous Kits Containing Recalled Devon Light Gloves

Stradis Healthcare is recalling 15 endovenous kits because they contain Devon Light Gloves, a component recalled by Medtronic.

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: The recall is a precautionary measure triggered by a component recall by another manufacturer (Medtronic). The source text does not report any illnesses, injuries, or specific hazards, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Stradis Healthcare, LLC. is recalling 15 units of Endovenous Kit, Endo Pack, and Endovenous Laser Kit. These kits are used during surgery and contain a component known as the Devon Light Glove.

The recall is being conducted because the manufacturer of the Devon Light Glove, Medtronic, has recalled that specific component. The source text does not specify the reason for Medtronic's recall of the gloves or report any illnesses or injuries associated with the Stradis kits.

The affected products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai. Consumers and healthcare facilities should stop using these kits and contact Stradis Healthcare for further instructions.

The recalled product

Product
Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
Affected units
15

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 (7)

  • Pack 682-156
  • 682-1548
  • 682-931
  • 682-493
  • 682-263
  • 682-1419
  • 682-044

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 51 recalled by Stradis Healthcare, LLC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 51 products in this recall →

Same manufacturer · Stradis Healthcare, LLC.

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