Surgical Procedure Kits Recalled for Incomplete Outer Bag Seal
Stradis Healthcare is recalling Varicosity Basic Pack surgical procedure kits (105 units) distributed in the US and Canada due to potentially incomplete outer bag sealing that may compromise sterility.
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 sterile medical devices with potential sterility breach due to manufacturing defect (incomplete outer bag sealing). No illnesses or injuries have been reported, qualifying this as a risk-of-harm product without reported injury per rubric Score 3 criteria.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Varicosity Basic Pack surgical procedure kits (Item No. 682-947, 105 units) distributed in the United States and Canada. The recalled kits have Lot Number 22236491032 and UDI/DI codes (case) M7526829471 and (kit) M7526829470.
The affected kits may have incompletely sealed outer bags due to certain manufacturing conditions. An incomplete seal could result in a breach in the sterility of the kit, potentially compromising the integrity of the medical device.
This is a precautionary recall based on the manufacturing defect, with no reported illnesses or injuries at this time.
The recalled product
- Product
- STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 105
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) M7526829471
- UDI/DI (kit)M7526829470
- Serial/Lot Numbers: 22236491032
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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