HCT 500mL Sterile Medical Bags Recalled for Potential Pinhole Leaks
Stradis Healthcare is recalling HCT 500mL sterile medical bags due to potential pinhole leaks near the seal that could compromise sterility. The recall affects 644 units distributed across nine U.S. 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: FDA Class II medical device recall of sterile medical bags with potential for sterility compromise due to pinhole leaks. No illnesses or injuries reported, making this a theoretical risk scenario for a high-risk product, classified as High per the rubric.
Plain-English summary
Stradis Healthcare, the manufacturer of HCT 500mL sterile medical bags, has recalled 644 units due to potential pinhole leaks near the outer bag seal. These leaks could compromise the sterility of the product, which is critical for safe medical use.
The affected product (Lot Number 220602531, UDI-DI: M752HCT105002) was distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
If you have received any of these bags, do not use them. Contact your healthcare facility or the manufacturer for instructions on returning the product.
The recalled product
- Product
- HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
- Manufacturer
- Stradis Healthcare
- Category
- Medical Device — Sterile Bags
- Hazard
- pinhole-leak
- sterile-breach
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 HCT10500
- UDI-DI: M752HCT105002
- Lot Number: 220602531
Distribution
Distributed nationwide across the United States.
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