Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk
Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 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: This is an FDA Class II medical device recall involving potential sterility breach in sterile medical bags. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product without reported injury scores 3 (High).
Plain-English summary
Stradis Healthcare is recalling HCT 50mL EVA bags (sterile, 2-port, triple-packaged) with Assembly Number HCT2050 and lot numbers 220130152 and 221677841. Approximately 2,779 units were distributed.
The bags may have pinhole leaks near the seal, which could compromise the sterility of the product. This represents a potential risk when these bags are used in medical applications requiring sterile conditions.
The affected products were distributed to the following U.S. states: Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. Healthcare facilities should check their inventory for the affected lot numbers.
The recalled product
- Product
- HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
- Manufacturer
- Stradis Healthcare
- Hazard
- pinhole-leak
- sterility-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 (4)
- Assembly Number HCT2050
- UDI-DI: M752HCT20502
- Lot Number: 220130152
- 221677841
Distribution
Distributed nationwide across the United States.
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