CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Wolf-Pak Dressing Change Kit recalled by Trinity Sterile
Trinity Sterile is recalling Wolf-Pak Dressing Change Kit with Cloth Border Tegaderm Dressing & CHG One Step, 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-1014-2025
- 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: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No
Where it was distributed
US Nationwide distribution in the states of MD, PA, TN and TX.
Questions about this recall
Is Wolf-Pak Dressing Change Kit with Cloth Border Tegaderm Dressing & CHG One Step recalled?
Yes. Trinity Sterile recalled Wolf-Pak Dressing Change Kit with Cloth Border Tegaderm Dressing & CHG One Step on 13 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-1014-2025.
Why was it recalled?
Potential for hole in package compromising sterility of the medical kit.
Which lots are affected?
Model No DC3080LF, UDI-DI 10857800006872, Lot Number 600022
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 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.
More recalls from Trinity Sterile
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|---|---|---|---|---|---|
| Device | CLASS II | Tacy Medical, Inc Dressing Change Tray CS/20 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 |
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