Stradis Healthcare Recalls Neurosurgery Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Neurosurgery Packs because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported or is unlikely to cause permanent harm.
Plain-English summary
Stradis Healthcare, LLC. is recalling Neurosurgery Packs that contain Devon Light Gloves. The recall is being conducted because the manufacturer of the gloves, Medtronic, has recalled the Devon Light Glove component.
The affected product is identified by Pack 888-2489. 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 return the product. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Neurosurgery Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- 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 888-2489
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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