Stradis Head and Neck Surgical Packs Recalled Due to Component Issue
Stradis Healthcare is recalling Head & Neck Packs containing Devon Light Gloves due to a manufacturer recall of 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 a precautionary measure triggered by a component recall, with no reported illnesses or injuries in the source text, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Head & Neck Packs, which are convenience kits used during surgery. The recall is being conducted because the kits contain a component, the Devon Light Glove, that is subject to a separate recall by its manufacturer, Medtronic.
The affected products are Pack 681-012 and 888-2385. The source text does not specify the exact quantity of units recalled, though the structured data indicates a quantity of 2. Distribution was 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, as well as to Canada and Dubai.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any illnesses or injuries associated with the product.
The recalled product
- Product
- Head & Neck Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 2
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 (2)
- Pack 681-012
- 888-2385
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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