The Recall Desk
ModerateFDA (Devices)·Z-2000-2015·Announced 2015-07-15

Stradis Healthcare Recalls Lipo/Buttocks Surgical Packs Due to Component Recall

Stradis Healthcare is recalling Lipo/Buttocks Packs because they contain a Devon Light Glove component 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: This is a Class II recall of a medical device component. The source text does not report any illnesses, injuries, or deaths, and the hazard is derived from the component manufacturer's recall rather than a direct reported safety failure of the kit itself.

Plain-English summary

Stradis Healthcare, LLC. is recalling one lot of Lipo/Buttocks Packs. These convenience kits are used during surgery and contain a Devon Light Glove. The recall is being conducted because the manufacturer of the glove, Medtronic, is recalling that specific component.

The affected product is identified by the code Pack 681-256. The kits 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 product was also distributed to Canada and Dubai.

Consumers and healthcare facilities should stop using these kits and contact Stradis Healthcare for instructions on how to return the product.

The recalled product

Product
Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery

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 681-256

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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