Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.
What this means for you
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 FDA Class II recall involves risk-of-harm for patients—sterility compromise in urinary catheter trays could lead to infection. No illnesses or injuries have been reported, supporting classification as High severity for a risk-of-harm product without documented injury.
Plain-English summary
Stradis Healthcare is recalling its Foley Catheter Insertion Tray with preconnected bag and catheter (sterile) due to a potential defect in the outer packaging. A total of 920 units are affected by this recall.
The outer bag may develop pinhole leaks near the seal, which could result in a breach of the kit's sterility. If the sterile barrier is compromised, the catheter and other kit components may be exposed to contamination, potentially affecting patient safety.
The affected products include Assembly Number 33066 and Assembly Number 33068 with associated lot numbers. The recalled units were distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. Healthcare facilities should identify affected inventory using the assembly and lot numbers.
Healthcare providers who have received these units should stop use immediately and return them to Stradis Healthcare. Patients or healthcare facilities with questions should contact Stradis Healthcare or their medical provider.
The recalled product
- Product
- Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
- Manufacturer
- Stradis Healthcare
- Affected units
- 920
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 (10)
- a. Assembly Number 33066
- UDI-DI: M752330661
- Lot Numbers: 222782334
- 222519530
- 222438660
- b. Assembly Number 33068
- UDI-DI: M752330681
- Lot Numbers: 222145412
- 220551558
- 222508466
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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