Stradis Healthcare Phlebectomy Pack Recall Due to Sterility Breach Risk
Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.
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: This Class II recall involves incomplete sealing of outer bags in surgical kits, which may compromise sterility. Per the severity rubric, Class II recalls describing risk-of-harm products with no reported illnesses or injuries qualify as 'High' severity (score 3).
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the STRADIS HEALTHCARE Phlebectomy Pack (Item No. 682-001), a medical and surgical procedure kit. The product was distributed nationwide throughout the United States and Canada, affecting 15 units.
The recall was initiated due to manufacturing conditions that may result in the outer bag being incompletely sealed. An incompletely sealed outer bag may result in a breach in the sterility of the kit.
The FDA classified this as a Class II recall.
The recalled product
- Product
- STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kit
- Affected units
- 15
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) M7526820011
- UDI/DI (kit)M7526820010
- Serial/Lot Numbers: 22236489633
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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