CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Tacy Medical, Inc Dressing Change Tray CS/20 recalled by Trinity Sterile
Trinity Sterile is recalling Tacy Medical, Inc Dressing Change Tray CS/20, distributed nationwide in the US. The recall was initiated on 13 Dec 2024 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-1016-2025
- FDA event ID
- 96068
- Recalling firm
- Trinity Sterile, Salisbury, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Dec 2024
- FDA classified
- 22 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Medical Software
Timeline
| 13 Dec 2024 | Recall initiated by company | |
| 22 Jan 2025 | Classified by FDA | +40 days |
| 29 Jan 2025 | 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 hole in package compromising sterility of the medical 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
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
Where it was distributed
US Nationwide distribution in the states of MD, PA, TN and TX.
Questions about this recall
Why was it recalled?
Potential for hole in package compromising sterility of the medical kit.
Which lots are affected?
Model No TM6180CP, UDI-DI 58500425700020, Lot Number 600032
Where was it sold?
US Nationwide distribution in the states of MD, PA, TN and TX.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96068This product is part of a recall event; the main page for the event is Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled | Trinity Sterile | Sterility | Nationwide | |
| CLASS II | IMed Products Dressing Change Kit with ChloraPrep & HaloGUARD recalled | Trinity Sterile | Sterility | Nationwide | |
| CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide | |
| CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
More recalls from Trinity Sterile
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | IMed Products Dressing Change Kit with ChloraPrep & HaloGUARD recalled | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 recalled | Trinity Sterile | Labeling Errors | Nationwide |
Other Medical Software recalls
All 932| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |