Central Line Insertion Trays Recalled for Potential Sterility Breaches
Stradis Healthcare is recalling HCT Central Line Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. Approximately 1,176 units were distributed nationwide.
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: FDA Class II recall of a sterile surgical device with potential for sterility breach and infection risk. No illnesses or injuries reported; the hazard is theoretical. Per the rubric, risk-of-harm products without reported injury score at the High level.
Plain-English summary
Stradis Healthcare is recalling HCT CENTRAL LINE Insertion Trays, model HCT8249CP-3. Approximately 1,176 units were distributed in the United States across Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
The outer packaging on affected units may contain pinhole leaks near the seal. These leaks could compromise the sterility of the insertion tray kit, potentially exposing patients to microbial contamination during central line placement procedures.
Affected lot numbers are: 222098152, 222551621, 221010141, 222309118, and 222901807. Healthcare facilities that received these trays should quarantine them pending further instructions from the manufacturer or the FDA.
No illnesses or adverse events have been reported to date. Healthcare providers with affected inventory should contact Stradis Healthcare or check the FDA's website for guidance on product replacement or return procedures.
The recalled product
- Product
- HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
- Manufacturer
- Stradis Healthcare
- Hazard
- sterility-breach
- infection-risk
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 (7)
- Assembly Number HCT8249CP-3
- UDI-DI: M752HCT8249CP30
- Lot Numbers: 222098152
- 222551621
- 221010141
- 222309118
- 222901807
Distribution
Distributed nationwide across the United States.
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