Stradis Suction Pack Recalled Due to Component Recall by Medtronic
Stradis Healthcare is recalling Suction Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.
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 classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a component recall without explicit high-risk pathogen or structural defect details, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Suction Packs that contain Devon Light Gloves. These products are used during surgery. The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has recalled the gloves.
The affected product is identified as Pack 670-057. 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 quantity of units recalled, specific dates of distribution, or reported illnesses or injuries. Consumers and healthcare facilities should check their inventory for Suction Packs with Pack 670-057 that contain Devon Light Gloves and stop using them if they match this description.
The recalled product
- Product
- Suction Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Hazard
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 670-057
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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