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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,175
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
Part of a larger recall action
This product is one of 18 recalled by Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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