The Recall Desk
ModerateFDA (Devices)·Z-2036-2015·Announced 2015-07-15

Stradis Healthcare Recalls Surgical Set Up Packs Containing Recalled Devon Light Gloves

Stradis Healthcare is recalling surgical Set Up 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 a component recall, with no specific injuries or illnesses reported in the source text.

Plain-English summary

Stradis Healthcare, LLC. is recalling Set Up Packs used during surgery. These convenience kits contain Devon Light Gloves, which are the subject of a separate recall by the manufacturer, Medtronic.

The affected product is identified by Pack 888-2546. The recall is limited to one unit. Distribution was nationwide in the United States to specific states, as well as Canada and Dubai.

Consumers and healthcare facilities should stop using the recalled Set Up Packs and contact Stradis Healthcare for further instructions.

The recalled product

Product
Set Up Pack - contains Devon Light Glove Used during surgery
Manufacturer
Stradis Healthcare, LLC.
Category
Medical Device — Surgical Consumables
Hazard
Affected units
1

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 888-2546

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 →

Related recalls

Same manufacturer · Stradis Healthcare, LLC.

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Same hazard · component recall

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