Stradis Gyn Pack Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling Gyn 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 source text describes a precautionary recall triggered by a component recall without reporting specific injuries, illnesses, or deaths, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Gyn Packs, which are convenience kits used during surgery. These kits 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 693-111. The distribution pattern indicates that these products were distributed 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. Additionally, the products were distributed to Canada and Dubai.
Consumers and healthcare facilities should stop using the affected Gyn Packs and contact Stradis Healthcare for further instructions regarding the recall.
The recalled product
- Product
- Gyn 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 693-111
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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