The Recall Desk
ModerateFDA (Devices)·Z-2023-2015·Announced 2015-07-15

Stradis Healthcare Recalls Eye Packs Containing Recalled Devon Light Gloves

Stradis Healthcare is recalling Eye Packs containing Devon Light Gloves due to a manufacturer recall of the glove component 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 action taken due to a component recall by the manufacturer, with no reported injuries or illnesses in the source text, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Stradis Healthcare, LLC. is recalling Eye Packs that contain Devon Light Gloves. These convenience kits are used during surgery. The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has recalled the gloves.

The affected product is identified by Pack 687-191. The distribution pattern includes the United States nationwide to specific states (AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA) as well as Canada and Dubai.

The source text does not specify the exact nature of the defect in the Devon Light Gloves or provide instructions for consumers on how to handle the recalled items. It is recommended to contact the recalling firm or the manufacturer for further guidance.

The recalled product

Product
Eye 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 687-191

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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