Stradis Arthroscopy Packs Recalled Due to Component Recall
Stradis Healthcare is recalling Arthroscopy Packs because they contain Devon Light Gloves, which are being recalled by the manufacturer 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 involves a medical device used during surgery (high-risk product) where the specific hazard is not detailed in the source text, but no injuries or illnesses have been reported, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Stradis Healthcare, LLC. is recalling Arthroscopy Packs that contain Devon Light Gloves. These packs are used during surgery. The recall is being conducted because the manufacturer of the gloves, Medtronic, is recalling the Devon Light Glove component.
The affected product is identified by the code Pack 888-2605. The distribution pattern includes the United States nationwide (specifically 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 Glove or report any specific injuries or illnesses associated with the use of these packs. Consumers and healthcare providers should stop using these packs and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Arthroscopy Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- 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 888-2605
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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