CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits recalled
Stradis Healthcare is recalling Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per, distributed nationwide in the US. The recall was initiated on 15 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0945-2023
- FDA event ID
- 91350
- Recalling firm
- Stradis Healthcare, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2022
- FDA classified
- 11 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 15 Dec 2022 | Recall initiated by company | |
| 11 Jan 2023 | Classified by FDA | +27 days |
| 18 Jan 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Where it was distributed
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Nationwide FloridaIllinoisIndianaMassachusettsMississippiNevadaOhioTennesseeTexasWashington
Questions about this recall
Is Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per recalled?
Yes. Stradis Healthcare recalled Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per on 15 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-0945-2023.
Why was it recalled?
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Which lots are affected?
Assembly Number TM.FFTK, UDI-DI: M752TMFFTK0, Lot Numbers: 220954416, 222418904, 221056552, 220070456, 220400116, 220411513, 220952568, 220943346, 221727862, 222709611, 222701385
Where was it sold?
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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