Stradis Vaginal Rejuvenation Pack Recalled Due to Component Recall
Stradis Healthcare is recalling Vaginal Rejuvenation Packs because they contain a Devon Light Glove component that Medtronic is recalling.
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 without specific reports of injury or illness in the source text, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling one Vaginal Rejuvenation Pack, identified by Pack 693-222. The product is a convenience kit used during surgery that contains a Devon Light Glove.
The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has recalled that specific item. The Vaginal Rejuvenation Pack is being recalled as a direct result of this component recall.
The affected product was 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. The product was also distributed to Canada and Dubai. Consumers and healthcare providers should check their inventory for this specific pack number and stop using the product if it is found.
The recalled product
- Product
- Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- 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 693-222
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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