Stradis Basic Pack Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling Basic Packs containing Devon Light Gloves because the manufacturer, Medtronic, is recalling the glove component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The agency classification is Class II, and the product is a medical device used during surgery. The recall is precautionary due to a component recall, with no specific injuries or illnesses reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Healthcare, LLC. is recalling Basic Packs that contain Devon Light Gloves used during surgery. The recall is being conducted because the manufacturer of the component, Medtronic, is recalling the Devon Light Glove.
The affected products are Basic Packs containing six Devon Light Gloves. The specific pack codes involved are 693-203, 888-2375, 888-2396, 888-2430, 888-2495, and 888-2594.
These products were distributed nationwide in the United States 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. The products were also distributed to Canada and Dubai. Users should stop using these products and contact Stradis Healthcare for further instructions.
The recalled product
- Product
- Basic Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Gloves
- Hazard
- Affected units
- 6
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 693-203
- 888-2375
- 888-2396
- 888-2430
- 888-2495
- 888-2594
Distribution
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.
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