Stradis Healthcare Medical Vein Kits Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Medical Vein procedure kits due to potentially incomplete sealing of the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
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 of medical procedure kits with potential sterility breach due to incomplete sealing. No illnesses or injuries have been reported, but the breach poses a risk of harm in surgical and medical procedure settings, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Healthcare (Stradis Medical, LLC) is recalling certain Medical Vein procedure kits, Item No. 682-330, due to a manufacturing defect affecting the outer bag seal.
During manufacturing, the outer bag of affected kits may be incompletely sealed. An incomplete seal may result in a breach of the kit's sterility, which could compromise the integrity of the medical supplies contained within.
The affected kits were distributed nationwide in the United States and in Canada. The recalled product has UDI/DI markings of M7526823301 (case) and M7526823300 (kit), with Serial/Lot Number 22238490518. Approximately 40 units have been identified as part of this recall.
Healthcare providers and individuals who have received these kits should immediately stop using them and contact Stradis Healthcare for instructions on replacement or disposal. If the kits have already been used, consult with a healthcare provider about any potential concerns.
The recalled product
- Product
- STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 40
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) M7526823301
- UDI/DI (kit)M7526823300
- Serial/Lot Numbers: 22238490518
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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