Stradis Pediatric Pack Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling Pediatric Packs containing Devon Light Gloves due to a manufacturer recall of the glove component 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 involves a medical device used during surgery (high-risk product) where the specific hazard is not detailed in the source text, and no injuries or illnesses are reported, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Healthcare, LLC. is recalling Pediatric 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, has issued a recall for that specific item.
The affected product is identified by Pack 888-2494. 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.
The source text does not specify the exact nature of the defect in the Devon Light Glove or report any specific injuries or illnesses. Consumers and healthcare facilities should stop using the affected Pediatric Packs and contact Stradis Healthcare or Medtronic for further instructions regarding the recall.
The recalled product
- Product
- Pediatric 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 888-2494
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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