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

Stradis Healthcare Recalls Skin and Vein Packs Containing Recalled Gloves

Stradis Healthcare is recalling Skin and Vein Packs because they contain Devon Light Gloves that Medtronic is recalling.

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 the recall of a component (gloves) by the manufacturer, with no specific injuries or illnesses reported in the source text.

Plain-English summary

Stradis Healthcare, LLC. is recalling Skin and Vein Packs that contain Devon Light Gloves. These packs are used during surgery. The recall is being conducted because the manufacturer of the gloves, Medtronic, is recalling the Devon Light Glove component.

The affected product is identified by Pack 682-1218. The quantity involved is 3 units. The products were distributed nationwide in the United States to specific states including Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Mexico, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. The products were also distributed to Canada and Dubai.

Consumers and healthcare facilities should stop using these specific packs and contact Stradis Healthcare for instructions on how to return or dispose of the product.

The recalled product

Product
Skin and Vein Pack - contains Devon Light Glove Used during surgery
Affected units
3

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)

  • Pack 682-1218

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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