CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report

Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled

Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30, 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

Lot, batch or date codesModel No DC5090LF, UDI-DI 10850007185722, Lot Number 600088

Quantity recalled5,940 units

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-1015-2025
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: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No

Where it was distributed

US Nationwide distribution in the states of MD, PA, TN and TX.

Nationwide Maryland Pennsylvania Tennessee Texas

Questions about this recall

Is Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled?

Yes. Trinity Sterile recalled Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 on 13 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-1015-2025.

Why was it recalled?

Potential for hole in package compromising sterility of the medical kit.

Which lots are affected?

Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088

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

All 10

Reported	Class	Recall	Company	Reason	Where
29 Jan 2025Device	CLASS II	Tacy Medical, Inc Dressing Change Tray CS/20 recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Dressing Change Kit recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Dressing Change Kit recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	IMed Products Dressing Change Kit with ChloraPrep & HaloGUARD recalled	Trinity Sterile	Sterility	Nationwide
24 Aug 2022Device	CLASS II	Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 recalled	Trinity Sterile	Labeling Errors	Nationwide

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