Wolf-Pak Dressing Change Kit Recall: Sterility Risk from Package Holes

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Contact the company & request your remedy

Recalling firmTrinity Sterile, Inc.201 Kiley Dr · Salisbury, MD 21801-2249

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Trinity Sterile Inc. is recalling Wolf-Pak Dressing Change Kits with transparent dressings and CHG applicators because holes in the packaging could compromise sterility. This risk matters because medical kits must stay sterile to prevent infections during wound care.

Why it’s dangerous

The packaging may develop holes that allow contaminants to enter the sterile kit. This could lead to infections if the kit is used without sterility, particularly during wound care procedures.

Who’s affected

Patients using these kits for wound care, especially those with open wounds or surgical sites. Healthcare providers and caregivers who use the kits for medical purposes are most at risk.

How to tell if you have this one

Check for the model number DC3077LF on the packaging. The lot number is 600018. The product was sold in cases of 30 kits, with 66 cases affected.

Brand
Wolf-Pak
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Integrity
Inspect the packaging for holes or damage that could compromise sterility.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The packaging may develop holes that could compromise sterility, risking infections during wound care.

How many units are affected?

66 cases (30 kits each) with lot number 600018.

Do I need to stop using this product?

If you find holes in the packaging, stop using the kit immediately. Otherwise, it's safe to use as long as the packaging is intact.

Take action

Contact Wolf-Pak

We’ve drafted a message you can send Wolf-Pak to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1013-2025 — Wolf-Pak Wolf-Pak

Hello,

I own a Wolf-Pak that is covered by recall Z-1013-2025 from Wolf-Pak.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1013-2025 (December 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1013-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Trinity Sterile, Inc. recalls Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30

Lower-risk recall