Surgical procedure kits recalled for incomplete seal and potential sterility breach
Stradis Healthcare is recalling medical surgical procedure trays and kits with potentially incomplete outer bag seals that could compromise sterility. These products were distributed nationwide in the US and Canada.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting a sterile medical device with a manufacturing defect (incomplete seal) that creates a sterility breach risk. No illnesses or injuries have been reported, but the hazard is significant as compromised sterility of surgical kits could lead to patient harm.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE Vasc Vein surgical procedure trays and kits (Item No. 682-1583), distributed nationwide in the US and Canada. The recall affects 20 units.
The outer bags of these medical kits may not be completely sealed due to certain manufacturing conditions. An incomplete seal creates a risk that the sterility of the kit could be breached, potentially exposing the sterile contents to contamination.
Healthcare facilities and consumers who have these products should stop using them and contact Stradis Healthcare for instructions. The affected lot number is 22237491038. The UDI/DI identifiers are M75268215830 (kit) and M75268215831 (case).
The recalled product
- Product
- STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Trays
- Affected units
- 20
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 (3)
- UDI/DI (case) M75268215831
- UDI/DI (kit)M75268215830
- Serial/Lot Numbers: 22237491038
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare 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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