The Recall Desk
ModerateFDA (Devices)·Z-2038-2015·Announced 2015-07-15

Stradis Healthcare Recalls Custom Surgical Packs Containing Recalled Devon Light Gloves

Stradis Healthcare is recalling Custom 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 measure triggered by a component recall without specific reports of injury or illness in the source text, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

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

The affected product is identified as Pack 888-2552. The distribution pattern includes the United States nationwide to specific states including 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, and WA, as well as Canada and Dubai.

Consumers and healthcare facilities should stop using the affected Custom Packs and contact Stradis Healthcare or Medtronic for instructions on how to return or dispose of the product.

The recalled product

Product
Custom Pack - contains Devon Light Glove Used during surgery
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 888-2552

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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