Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
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 is an FDA Class II medical device recall involving a potential sterility breach. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed. Per the severity rubric, this meets the criterion for 'High' severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stradis Healthcare is recalling the TCTR Convenience Kit (Lot Number 222014334) distributed nationwide. The kit is affected by the potential for the outer bag to have pinhole leaks near the seal.
These pinhole leaks may result in a breach in the sterility of the kit. A compromised sterile barrier could allow contamination of the medical device or its contents.
The recall involves 80 units distributed across ten states: Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
Customers in possession of the affected TCTR Convenience Kit should stop use and contact Stradis Healthcare or the FDA for instructions on return or replacement.
The recalled product
- Product
- Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
- Manufacturer
- Stradis Healthcare
- Affected units
- 80
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)
- Assembly Number TCTR01
- UDI-DI: M752TCTR011
- Lot Numbers: 222014334
Distribution
Part of a larger recall action
This product is one of 18 recalled by 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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