The Recall Desk
ModerateFDA (Devices)·Z-1999-2015·Announced 2015-07-15

Stradis Healthcare Recalls Lipo Packs Containing Recalled Devon Light Gloves

Stradis Healthcare is recalling Lipo Packs, Expended Packs, and Trays 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 action taken because a component (Devon Light Glove) is being recalled by its manufacturer. The source text does not report any illnesses, injuries, or specific defects, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Stradis Healthcare, LLC. is recalling 13 units of Lipo Pack, Liposuction Expended Pack, and Liposuction Tray products. These convenience kits are being recalled because they contain a component, the Devon Light Glove, which is subject to a separate recall by its manufacturer, Medtronic.

The affected 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.

The specific product codes involved are 681-025, 681-268, 681-254, 681-013, 681-506, and 888-2587. The source text does not specify the exact nature of the defect in the Devon Light Glove or the specific health risks associated with its use. Consumers and healthcare providers should stop using these kits and contact Stradis Healthcare or Medtronic for further instructions regarding the component recall.

The recalled product

Product
Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Affected units
13

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 (6)

  • Pack 681-025
  • 681-268
  • 681-254
  • 681-013
  • 681-506
  • 888-2587

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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