HCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach
Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.
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 is an FDA Class II recall of sterile medical equipment with a potential defect that could compromise sterility. No illnesses or injuries have been reported, but the product represents a risk-of-harm category where infection could result from loss of sterility, meeting the rubric criterion for High severity.
Plain-English summary
Stradis Healthcare, through distributor Health Care Technology, is recalling the HCT MAX BARRIER PICC INSERTION TRAY (12 per case, 200 units affected) due to a potential manufacturing defect. The outer bag may develop pinhole leaks near the seal, which could breach the sterility of the insertion kit.
The recalled lot (Lot Number 222218373, UDI-DI: M752HCT8428CP20) was distributed nationwide to hospitals and healthcare facilities in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
Sterile insertion equipment is critical for patient safety during PICC line placement procedures. A breach in sterility could expose patients to infection risk. While no illnesses or injuries have been reported to date, healthcare facilities should immediately identify and quarantine affected inventory.
If you received this product, stop using the affected lot immediately. Contact Stradis Healthcare or Health Care Technology for instructions on replacement or disposal.
The recalled product
- Product
- HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
- Manufacturer
- Stradis Healthcare
- Category
- Medical Device
- Hazard
- sterility-breach
- packaging-defect
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 HCT8428CP-2
- UDI-DI: M752HCT8428CP20
- Lot Number: 222218373
Distribution
Distributed nationwide across the United States.
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