Stradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.
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 a sterile medical device with a potential breach in sterility assurance. No illnesses or injuries have been reported. The hazard is theoretical—a potential defect that could compromise the sterile field—and per the rubric, recalls with no reported harm and theoretical hazards score at most 3 (High).
Plain-English summary
Stradis Healthcare is recalling 600 units of Tacy Medical, Inc PORT ACCESS TRAY (Sterile, QTY 20) due to a potential defect in the outer bag packaging. The outer bag may have pinhole leaks near the seal, which could compromise the sterility of the kit.
The affected units include Assembly Number TM8823-1, UDI-DI: M752TM882310, and Lot Number: 220110674. These units were distributed in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, and WA.
Healthcare facilities and users in the affected states who have received these kits should verify the lot number and assembly number. If units from this recall are identified, they should not be used. Contact Stradis Healthcare or the FDA if you have questions about whether your inventory is affected.
The recalled product
- Product
- Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
- Manufacturer
- Stradis Healthcare
- Hazard
- sterility-breach
- contamination-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 (3)
- Assembly Number TM8823-1
- UDI-DI: M752TM882310
- Lot Number: 220110674
Distribution
Distributed nationwide across the United States.
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