Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed 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 of surgical procedure kits with a manufacturing defect that could compromise sterility. The incomplete sealing of outer bags raises a risk of contamination of surgical instruments, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Vein & Laser surgical procedure trays and kits (Item No. 682-334R1). The recall affects 10 units distributed nationwide in the United States and Canada, with lot/serial number 22231489619.
During manufacturing, the outer bags of these surgical kits may have been incompletely sealed. An incomplete seal can result in a breach of the kit's sterility, which is critical for safe surgical use.
The recalled product
- Product
- STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 10
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) M752682334R11
- UDI/DI (kit)M752682334R10
- Serial/Lot Numbers: 22231489619
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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