Stradis Healthcare Recalls Phleb Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Phleb Packs and Laser Phleb Packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 (Devon Light Glove) without explicit 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 Phleb Packs and Laser Phleb Packs. These convenience kits are used during surgery and 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 products include specific pack codes: 682-1284, 682-299, 682-410, 682-353, 682-377, and 682-548. A total of 9 units were distributed. The products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai.
Healthcare facilities and consumers should stop using these kits and contact Stradis Healthcare for instructions on how to return the affected products.
The recalled product
- Product
- Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 9
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 (6)
- Pack 682-1284
- 682-299
- 682-410
- 682-353
- 682-377
- 682-548
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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