Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine 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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a theoretical risk of sterility breach from pinhole leaks in the outer bag. Per the rubric, a risk-of-harm product where injury has not yet been reported receives a score of 3 (High).
Plain-English summary
Stradis Healthcare is recalling 1,175 units of the Tacy Medical Fluid Filter Transfer Kit due to a potential defect affecting product sterility.
The outer bag of the kit may develop pinhole leaks near the seal. These leaks could compromise the sterility of the kit and potentially allow contamination of the product.
The recalled kits were distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. The affected lot numbers are: 220954416, 222418904, 221056552, 220070456, 220400116, 220411513, 220952568, 220943346, 221727862, 222709611, and 222701385.
Organizations that have received affected kits should contact Stradis Healthcare.
The recalled product
- Product
- Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. 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 (13)
- Assembly Number TM.FFTK
- UDI-DI: M752TMFFTK0
- Lot Numbers: 220954416
- 222418904
- 221056552
- 220070456
- 220400116
- 220411513
- 220952568
- 220943346
- 221727862
- 222709611
- 222701385
Distribution
Distributed nationwide across the United States.
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