Wolf-Pak Premium Dressing Change Kit Recall: Sterility Risk from Package Holes
Trinity Sterile Inc. recalls Wolf-Pak Premium Dressing Change Kits (DC5090LF) due to potential package holes that could compromise sterility. Affected lots: 600088, 198 cases. Contact for remedy.
Lower-risk recall
Potential for hole in package compromising sterility of the medical kit.
Contact the company
What happened, in plain English
Trinity Sterile Inc. is recalling Wolf-Pak Premium Dressing Change Kits with GuardiVa & Statlock CS/30 (model DC5090LF) because holes in the packaging might let contaminants enter, making the medical kit unsafe for use. This could lead to infections if the kit is used without proper sterility. Read more at govinfonow.com/recall/53297-wolf-pak-premium-dressing-change-kit-recall-sterility-risk-from.
Source Summary by GovInfoNow · govinfonow.com/recall/53297-wolf-pak-premium-dressing-change-kit-recall-sterility-risk-from · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1015-2025
Cite this page
“Wolf-Pak Premium Dressing Change Kit Recall: Sterility Risk from Package Holes.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53297-wolf-pak-premium-dressing-change-kit-recall-sterility-risk-from. Based on FDA recall #Z-1015-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1015-2025%22&limit=1).
Why it’s dangerous
The packaging may develop holes that allow contaminants to enter the sterile dressing kit. If the kit is used without proper sterility, it could lead to infections in patients.
Who’s affected
Patients using medical dressings at home or in healthcare settings who received the affected lot (600088) of the Wolf-Pak Premium Dressing Change Kit (DC50:90LF) are most at risk.
How to tell if you have this one
Check for the model number DC5090LF on the packaging. The affected lot number is 600088, with 198 cases recalled. The product was sold in 198 cases.
- Brand
Wolf-Pak- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of MD, PA, TN and TX.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1012-2025 | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No; Model No IM46062, UDI-DI 10853155008769, Lot Number 600022 | 1,980 units |
| Z-1013-2025 | Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No; Model No DC3077LF, UDI-DI 10857800006841, Lot Number 600018 | 1,980 units |
| Z-1014-2025 | 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; Model No DC3080LF, UDI-DI 10857800006872, Lot Number 600022 | 3,960 units |
| Z-1015-2025 | 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; Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088 | 5,940 units |
| Z-1016-2025 | 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; Model No TM6180CP, UDI-DI 58500425700020, Lot Number 600032 | 280 units |
What to do — step by step
Check Product Details
Look for model DC5090LF and lot number 600088 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “US Nationwide distribution in the states of MD, PA, TN and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-1015-2025 (December 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1015-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.